CN109557311A - Colorectal cancer diagnosis marker, colorectal cancer detection product and application thereof - Google Patents
Colorectal cancer diagnosis marker, colorectal cancer detection product and application thereof Download PDFInfo
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- CN109557311A CN109557311A CN201811524741.4A CN201811524741A CN109557311A CN 109557311 A CN109557311 A CN 109557311A CN 201811524741 A CN201811524741 A CN 201811524741A CN 109557311 A CN109557311 A CN 109557311A
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- albumen
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- tenascin
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- 206010009944 Colon cancer Diseases 0.000 title claims abstract description 87
- 208000001333 Colorectal Neoplasms Diseases 0.000 title claims abstract description 79
- 238000003745 diagnosis Methods 0.000 title claims abstract description 37
- 239000003550 marker Substances 0.000 title claims abstract description 19
- 238000001514 detection method Methods 0.000 title claims abstract description 15
- 108010052495 Calgranulin B Proteins 0.000 claims abstract description 50
- 102000018755 Calgranulin B Human genes 0.000 claims abstract 15
- 210000002966 serum Anatomy 0.000 claims description 44
- 238000012360 testing method Methods 0.000 claims description 43
- 230000008676 import Effects 0.000 claims description 10
- 210000002381 plasma Anatomy 0.000 claims description 10
- 210000001072 colon Anatomy 0.000 claims description 9
- 201000010989 colorectal carcinoma Diseases 0.000 claims description 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 9
- 210000000664 rectum Anatomy 0.000 claims description 9
- 210000005259 peripheral blood Anatomy 0.000 claims description 7
- 239000011886 peripheral blood Substances 0.000 claims description 7
- 206010009900 Colitis ulcerative Diseases 0.000 claims description 6
- 201000006704 Ulcerative Colitis Diseases 0.000 claims description 6
- 206010009887 colitis Diseases 0.000 claims description 4
- 208000025865 Ulcer Diseases 0.000 claims description 3
- 230000036541 health Effects 0.000 claims description 3
- 231100000397 ulcer Toxicity 0.000 claims description 3
- 239000003153 chemical reaction reagent Substances 0.000 claims description 2
- 230000035945 sensitivity Effects 0.000 abstract description 10
- 102000004169 proteins and genes Human genes 0.000 abstract description 7
- 108090000623 proteins and genes Proteins 0.000 abstract description 7
- 239000012474 protein marker Substances 0.000 abstract description 4
- 102000040739 Secretory proteins Human genes 0.000 abstract description 3
- 108091058545 Secretory proteins Proteins 0.000 abstract description 3
- 102100022019 Pregnancy-specific beta-1-glycoprotein 2 Human genes 0.000 abstract 1
- 102100032420 Protein S100-A9 Human genes 0.000 description 36
- 206010028980 Neoplasm Diseases 0.000 description 16
- 201000011510 cancer Diseases 0.000 description 14
- 208000029742 colonic neoplasm Diseases 0.000 description 9
- 238000000034 method Methods 0.000 description 7
- 102100038126 Tenascin Human genes 0.000 description 6
- 201000010099 disease Diseases 0.000 description 5
- 238000004458 analytical method Methods 0.000 description 4
- 230000004069 differentiation Effects 0.000 description 4
- 238000011160 research Methods 0.000 description 4
- QCVGEOXPDFCNHA-UHFFFAOYSA-N 5,5-dimethyl-2,4-dioxo-1,3-oxazolidine-3-carboxamide Chemical compound CC1(C)OC(=O)N(C(N)=O)C1=O QCVGEOXPDFCNHA-UHFFFAOYSA-N 0.000 description 3
- 102000002322 Egg Proteins Human genes 0.000 description 3
- 108010000912 Egg Proteins Proteins 0.000 description 3
- 201000003741 Gastrointestinal carcinoma Diseases 0.000 description 3
- 235000014103 egg white Nutrition 0.000 description 3
- 210000000969 egg white Anatomy 0.000 description 3
- 235000013601 eggs Nutrition 0.000 description 3
- 230000002757 inflammatory effect Effects 0.000 description 3
- 201000002313 intestinal cancer Diseases 0.000 description 3
- 230000036470 plasma concentration Effects 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 238000009007 Diagnostic Kit Methods 0.000 description 2
- 241000282414 Homo sapiens Species 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 238000013399 early diagnosis Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 238000004393 prognosis Methods 0.000 description 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
- 208000032177 Intestinal Polyps Diseases 0.000 description 1
- 101710156990 Protein S100-A9 Proteins 0.000 description 1
- 102000007000 Tenascin Human genes 0.000 description 1
- 108010008125 Tenascin Proteins 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000009534 blood test Methods 0.000 description 1
- 102000014823 calbindin Human genes 0.000 description 1
- 108060001061 calbindin Proteins 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 238000002052 colonoscopy Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229960002897 heparin Drugs 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- 238000003364 immunohistochemistry Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000007477 logistic regression Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000001819 mass spectrum Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000012113 quantitative test Methods 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 210000001599 sigmoid colon Anatomy 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000439 tumor marker Substances 0.000 description 1
- 238000005109 two-dimensional liquid chromatography tandem mass spectrometry Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
- G01N33/57419—Specifically defined cancers of colon
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
- G01N33/57446—Specifically defined cancers of stomach or intestine
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
- G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
- G01N2333/4701—Details
- G01N2333/4746—Cancer-associated SCM-recognition factor, CRISPP
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/06—Gastro-intestinal diseases
- G01N2800/065—Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
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Abstract
The invention relates to a colorectal cancer diagnosis marker, a colorectal cancer detection product and application thereof. The colorectal cancer diagnosis marker comprises a plurality of secretory proteins, wherein the secretory proteins comprise one or two of S100A9 protein and tenascin-c protein, and CEA protein. The kit has the characteristics of high sensitivity and strong specificity, the area under the roc curve of a diagnosis model is 0.902, the reliability of a diagnosis result is far higher than that of a diagnosis result obtained by adopting a single protein marker, and the kit has great significance for diagnosis and treatment of colorectal cancer. The colorectal cancer detection product comprises the colorectal diagnosis marker. The invention also provides application of the colorectal diagnosis marker in preparation of products for assisting in diagnosis of colorectal cancer.
Description
Technical field
The present invention relates to the detections of pharmaceutical technology field more particularly to a kind of diagnosis of colorectal carcinoma marker and colorectal cancer
Product and its application.
Background technique
Colorectal cancer is one of most common malignant tumor of digestive tract in the whole world, in the past 20 years the disease incidence of colon cancer and dead
Dying rate, most countries are all in rising trend in the world, and most of colorectal cancer patients discovery has been advanced stage, and prognosis is poor.Mesh
The method of preceding screening and diagnosis for colon cancer be all it is aggressive, Sigmoidoscope is still the goldstandard of its sieving and diagnosis.In recent years
Come, stool occult blood test is in colorectal cancer screening using most common non-intrusive inspection method, still, sensitivity and spy
Different degree is lower.If simple serum detection can be applied to its early diagnosis, it will help the prevention and prognosis of colon cancer.
The widely used colon tumor marker of Present clinical substantially increases the diagnosis of colon cancer, reduces the death rate and recurrence rate, but
Their sensitivity and specificity are not high.Therefore, they are very limited as the effect of the marker of colon cancer early diagnosis.
On this basis, it is therefore desirable to be able to explore and develop more tumor markers relevant to colon cancer.
Ulcerative colitis and inflammatory intestinal polyp are often considered as one of the high risk factor of Colorectal Cancer, are examined using colonoscopy
It surveys and check is invasive inspection, patient is very inconvenient during detecting progression of disease.Therefore, it is necessary to a kind of detection sides
Method, can it is noninvasive tracking disease progress, early detection and diagnosis colorectal cancer, instruct the treatment of colorectal cancer patients.
Summary of the invention
Technical problem to be solved by the invention is to provide the detections of a kind of diagnosis of colorectal carcinoma marker and colorectal cancer
Product and its application.
The present invention proposes a kind of diagnosis of colorectal carcinoma marker, including S100A9 albumen and the (abbreviation of tenascin-c albumen
For TNC albumen) one or both of and CEA albumen.
Furthermore the answering in the testing product of preparation detection colorectal cancer the invention also provides Colon and rectum diagnosis marker
With.
In addition, the present invention also proposes a kind of testing product of colorectal cancer, including Colon and rectum diagnostic markers described above
Object.
Preferably, the testing product is diagnostic kit.
Preferably, the serum and at least one non-knot that the testing product is used to distinguish at least one colorectal cancer patients are directly
The serum of patients with bowel cancer and/or the testing product are used to distinguish the serum and a health of at least one colorectal cancer patients
The serum of individual and/or the testing product are used to distinguish the serum and at least one ulcer of at least one colorectal cancer patients
The serum of property colitis disease.
Preferably, the testing product further includes the serum for distinguishing at least one colorectal cancer patients and at least one
First regression model of the serum of non-colorectal cancer patients, the identification function that first regression model establishes P is P=1/ { 1
+ exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein X is the concentration of CEA albumen, unit ng/mL;Y is
The concentration of S100A9 albumen, unit ng/mL;Z is the concentration of tenascin-c albumen, unit ng/mL;Wherein, P value is critical
Value is 0.62;
And/or the testing product further includes serum for distinguishing at least one colorectal cancer patients and at least one
Second regression model of the serum of healthy individuals, second regression model establish P identification function be P=1/ 1+exp [-
(- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein X is the concentration of CEA albumen, unit ng/mL;Y is S100A9 egg
White concentration, unit ng/mL;Z is the concentration of tenascin-c albumen, unit ng/mL;Wherein, P value critical value is
0.71;
And/or the testing product further includes serum for distinguishing at least one colorectal cancer patients and at least one
The third regression model of the serum of patients of ulcerative colitis, the identification function that the third regression model establishes P is P=1/
{ 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein X is the concentration of CEA albumen, unit ng/mL;Y is
The concentration of S100A9 albumen, unit ng/mL;Z is the concentration of tenascin-c albumen, unit ng/mL;Wherein, P value is critical
Value is 0.67.
Further, further include computer readable carrier, record program in the computer readable carrier, when the meter
When the readable carrier of calculation machine is executed by processor, perform the steps of
The concentration of CEA albumen, the concentration of S100A9 albumen and tenascin-c albumen in interpretation person under test's peripheral blood blood plasma
Concentration;
The concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen is led
Enter identification function P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein P value critical value is
0.62;
And/or by the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
Concentration imports identification function P=1/ { 1+exp [- (- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein P value critical value
It is 0.71;
And/or by the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
Concentration imports identification function P=1/ { 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein P value critical value
It is 0.67;Wherein, X is the concentration of CEA albumen, unit ng/mL;Y is the concentration of S100A9 albumen, unit ng/mL;Z is
The concentration of tenascin-c albumen, unit ng/mL.
The invention also includes the product for detecting S100A9 albumen and/or the products for detecting tenascin-c albumen
Application in product of the preparation for auxiliary diagnosis colorectal cancer.
Further, the invention also includes the product for detecting tenascin-c albumen and/or for detecting S100A9
One or both of product of albumen and product for detecting CEA albumen and computer readable carrier are assisted in preparation
Diagnose the application in the product of colorectal cancer, wherein program is recorded in the computer readable carrier, when the computer can
When reading carrier is executed by processor, perform the steps of
The concentration of CEA albumen, the concentration of S100A9 albumen and tenascin-c albumen in interpretation person under test's peripheral blood blood plasma
Concentration;
The concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen is led
Enter identification function P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein P value critical value is
0.62;
And/or by the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
Concentration imports identification function P=1/ { 1+exp [- (- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein P value critical value
It is 0.71;
And/or by the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
Concentration imports identification function P=1/ { 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein P value critical value
It is 0.67;
Wherein, X is the concentration of CEA albumen, unit ng/mL;Y is the concentration of S100A9 albumen, unit ng/mL;Z is
The concentration of tenascin-c albumen, unit ng/mL.
The beneficial effect of the present invention compared with the prior art includes: that diagnosis of colorectal carcinoma marker proposed by the present invention is being examined
In disconnected colorectal cancer, have the characteristics that high sensitivity, high specificity, roc area under the curve (the area under of diagnostic model
The curve, AUC) it is 0.902, diagnostic result confidence level significantly larger than uses individual protein marker, for colorectal cancer
Diagnosing and treating is of great significance.The testing product of colorectal cancer including Colon and rectum diagnosis marker is for distinguishing at least one
The serum and/or the testing product of the serum of a colorectal cancer patients and at least one non-colorectal cancer patients are for distinguishing
The serum and/or the testing product of the serum of at least one colorectal cancer patients and healthy individuals are for distinguishing at least
The serum of one colorectal cancer patients and the serum of at least one patients of ulcerative colitis.
Detailed description of the invention
The features and advantages of the present invention will be more clearly understood by referring to the accompanying drawings, and attached drawing is schematically without that should manage
Solution is carries out any restrictions to the present invention, in the accompanying drawings:
Fig. 1 be three kinds of albumen individually and the ROC curve figure of combined diagnosis colorectal cancer.
Specific embodiment
In order to make the foregoing objectives, features and advantages of the present invention clearer and more comprehensible, with reference to the accompanying drawing to the present invention
Specific embodiment be described in detail.Embodiment below facilitates a better understanding of the present invention, but does not limit the present invention.
Experimental method in following embodiments is unless otherwise specified conventional method.Test material as used in the following examples,
It unless otherwise specified, is to be commercially available from routine biochemistry reagent shop.Quantitative test in following embodiment, is respectively provided with two
Hole repeats to test, and results are averaged.
The goldstandard of diagnosis of colorectal carcinoma is pathological examination result.
Embodiment
Peripheral blood serum sample collection method: early morning acquires the periphery 10mL blood vains sample on an empty stomach, and it is small to be stored at room temperature two
When, speed is that 1000g is centrifuged 15min at 4 DEG C, separates upper plasma, and save backup in -80 DEG C.
The number for detecting the Elisa kit of Tenascin-c is CSB-E13125h;
The number for detecting the Elisa kit of S100A9 is CSB-E11834h;
The number for detecting the Elisa kit of CEA is CSB-E04767h.
Research object
Collection Xiangya Hospital, Central-South China Univ. has passed through pathological examination in March, -2018 in 2017 and has been diagnosed as colorectal cancer
Peripheral blood 258 of patient.Wherein, male 148, women 110.Informed consent agreement and search procedure obtain ethics committee
The approval of member's meeting, and agree to that all patients for participating in this research and healthy volunteer sign informed consent form.
Determine protein marker
In the present embodiment, the proteomics research of colon cancer is carried out early period, has passed through detection wind lidar
(LCM), the combination research colorectal cancer different phase of iTRAQ label and two-dimensional liquid chromatography-tandem mass spectrum (2D LC-MS/MS)
Stroma protein group, altogether screening obtain 222 differentially expressed proteins.By analysis and immunohistochemistry is verified, it is thus identified that
S100A9 and tenascin-c is the biggish secretory protein of differential expression, and the clinical tumor of alternatively colon cancer marks
Object.
S100A9 (Chinese calbindin S100A9, English name protein S100-A9, gi | 4506773);
Tenascin-c (Chinese tenascin Tenascin-c, English name protein Tenascin-c, gi |
1842130, abbreviation TNC);
By this two kinds of markers and clinical common tumor markers CEA joint-detection.
ELISA detection verifying
Take above-mentioned Patients with Colorectal Cancer periphery blood plasma 258, human normal plasma 103, benign colorectal diseases patient blood
99, slurry, is carried out according to kit specification detection, and EDTA or heparin is used to collect blood plasma as anticoagulant.After collecting blood plasma
30 minutes in 1000 × g, 2-8 DEG C is centrifuged 15 minutes, measures immediately, obtains the concentration of three kinds of albumen of 460 samples.
(specific method kit specification is described)
Critical value determines
Using spss software carry out logistic regression analysis, colorectal cancer patients are named as " 1 ", by control group (Healthy People or/
With Sigmoid Colon inflammation patient) it is named as " 0 ", S100A9 is accordingly inputted, the concentration of TNC, CEA set disease type in spss
For " dependent variable ", " independent variable " is set by the concentration of three, three formula about P value are obtained by logic analysis.Analysis
Show that (P value is the value that logic analysis obtains to P value, and the concentration value of the CEA of each case, S100A9, TNC are different, p value
Difference can be considered one " detected value " calculated according to our model) after, ROC curve production is carried out, maximum diagnosis effect is obtained
Critical value when rate, the critical value are a specific P value, are considered as " positive " higher than this value, are considered as " feminine gender " lower than this value, point
Not Fen Xi cancer sample and inflammation (benign Colon and rectum patient, be also possible to patients of ulcerative colitis) sample P value it is critical
Value, the P value critical value of cancer sample and Healthy People sample, the P value critical value of cancer sample and non-cancer sample.It is more than or equal to
Cutoff value is illness (i.e. positive), lower than as negative findings.It should be noted that non-cancer includes Healthy People and inflammation
Disease.Three formula about P value are as follows:
Distinguish the formula about P value of Healthy People and cancer patient are as follows:
P=1/ { 1+exp [- (- 3.7801+0.22*X+0.17*Y+0.5*Z)] } (cutoff:p >=0.71);It is more than or equal to
0.71 is cancer patient, is Healthy People less than 0.71;
Distinguish the formula about P value of inflammatory patients and cancer patient are as follows:
P=1/ { 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] } (cutoff:p >=0.67);It is more than or equal to
0.67 is cancer patient, is inflammatory patients less than 0.67;
Distinguish the formula about P value of cancer patient and non-cancer are as follows:
P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] } (cutoff:p >=0.62);It is more than or equal to
0.62 is cancer patient, is non-cancer less than 0.62.
Table 1 be three kinds of albumen individually and the specificity and susceptibility of combined diagnosis colorectal cancer
CEA | S100A9 | TNC | Diagnostic model | |
Colorectal cancer patients VS Healthy People | 3.23 | 18.74 | 3.87 | - |
Youden index | 0.35 | 0.56 | 0.5 | 0.69 |
Sensitivity (%) | 44.2 | 64.7 | 57 | 78.3 |
Specificity (%) | 90.3 | 91.3 | 93.2 | 90.3 |
The benign Colon and rectum patient of colorectal cancer patients vs | 3.36 | 17.06 | 2.43 | - |
Youden index | 0.39 | 0.56 | 0.5 | 0.68 |
Sensitivity (%) | 44.2 | 68.2 | 70.9 | 81.8 |
Specificity (%) | 94.9 | 87.9 | 79.8 | 85.9 |
Table 2 is three kinds of albumen area individually and under the ROC curve of combined diagnosis colorectal cancer
Variable | AUC | SEa | 95%Clb |
CEA | 0.736 | 0.0227 | 0.693 to 0.776 |
S100A9 | 0.831 | 0.0186 | 0.793 to 0.864 |
TNC | 0.728 | 0.0232 | 0.685 to 0.769 |
model | 0.902 | 0.0142 | 0.872 to 0.928 |
From table 1 it is known that the sensitivity for the diagnostic model that three kinds of protein combinations are established is 81.9%, specificity is
85.9%.It is better than the sensitivity that three kinds of albumen individually detect.Sensitivity and specificity are clinically difficult to take into account, and are promoting spirit
While sensitivity, specificity will certainly be lowered, and youden index can be used as the comprehensive standard for measuring diagnosis efficiency, can from table 1
To find out the youden index highest of the diagnostic model of three kinds of protein combinations foundation.From Fig. 1 and table 2 it is known that three kinds of protein groups
The AUC value for building vertical diagnostic model jointly is 0.902, hence it is evident that higher than the AUC value that three kinds of albumen individually detect, diagnostic result confidence level
Individual protein marker is significantly larger than used, is of great significance for diagnosis of colorectal carcinoma and treatment.
Therefore, the present embodiment proposes a kind of diagnosis of colorectal carcinoma marker, including S100A9 albumen and tenascin-c egg
One or both of white and CEA albumen.
Furthermore, it is also proposed that a kind of testing product of colorectal cancer, including Colon and rectum diagnosis marker described above.
Preferably, the testing product is diagnostic kit.
Preferably, the serum and at least one non-knot that the testing product is used to distinguish at least one colorectal cancer patients are directly
The serum of patients with bowel cancer and/or the testing product are used to distinguish the serum and a health of at least one colorectal cancer patients
The serum of individual and/or the testing product are used to distinguish the serum and at least one ulcer of at least one colorectal cancer patients
The serum of property colitis disease.
The testing product further includes straight for distinguishing the serum of at least one colorectal cancer patients and at least one non-knot
First regression model of the serum of patients with bowel cancer, first regression model establish P identification function be P=1/ 1+exp [-
(- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein X is the concentration of CEA albumen, unit ng/mL;Y is S100A9 egg
White concentration, unit ng/mL;Z is the concentration of tenascin-c albumen, unit ng/mL;Wherein, P value critical value is
0.62;
And/or the testing product further includes serum for distinguishing at least one colorectal cancer patients and at least one
Second regression model of the serum of healthy individuals, second regression model establish P identification function be P=1/ 1+exp [-
(- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein X is the concentration of CEA albumen, unit ng/mL;Y is S100A9 egg
White concentration, unit ng/mL;Z is the concentration of tenascin-c albumen, unit ng/mL;Wherein, P value critical value is
0.71;
And/or the testing product further includes serum for distinguishing at least one colorectal cancer patients and at least one
The third regression model of the serum of patients of ulcerative colitis, the identification function that the third regression model establishes P is P=1/
{ 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein X is the concentration of CEA albumen, unit ng/mL;Y is
The concentration of S100A9 albumen, unit ng/mL;Z is the concentration of tenascin-c albumen, unit ng/mL;Wherein, P value is critical
Value is 0.67.The testing product can by one of three kinds of models or it is a variety of differentiated, obtain a kind of differentiation result or
A variety of differentiation results.
The present embodiment further includes application of the Colon and rectum diagnosis marker in the testing product of preparation detection colorectal cancer.
In addition, the present embodiment also proposes product for detecting S100A9 albumen and/or for detecting tenascin-c egg
Application of the white product in the product that preparation is used for auxiliary diagnosis colorectal cancer.
Finally, the present embodiment also proposes product for detecting tenascin-c albumen and/or for detecting S100A9 egg
One or both of white product and product for detecting CEA albumen and computer readable carrier are examined in preparation auxiliary
Application in the product of disconnected colorectal cancer, wherein program is recorded in the computer readable carrier, when described computer-readable
When carrier is executed by processor, perform the steps of
The concentration of CEA albumen, the concentration of S100A9 albumen and tenascin-c albumen in interpretation person under test's peripheral blood blood plasma
Concentration;
The concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen is led
Enter identification function P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein P value critical value is
0.62;
And/or by the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
Concentration imports identification function P=1/ { 1+exp [- (- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein P value critical value
It is 0.71;
And/or by the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
Concentration imports identification function P=1/ { 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein P value critical value
It is 0.67;Wherein, X is the concentration of CEA albumen, unit ng/mL;Y is the concentration of S100A9 albumen, unit ng/mL;Z is
The concentration of tenascin-c albumen, unit ng/mL.The concentration of three kinds of albumen can be directed through in three kinds of identification functions
It is one or more differentiated, obtain a kind of differentiation result or a variety of differentiation results.
Unless otherwise defined, all technical and scientific terms used herein and belong to technical field of the invention
The normally understood meaning of technical staff is identical.Term as used herein in the specification of the present invention is intended merely to description tool
The purpose of the embodiment of body, it is not intended that in the limitation present invention.Each technical characteristic of embodiment described above can carry out arbitrarily
Combination, for simplicity of description, it is not all possible to each technical characteristic in above-described embodiment combination be all described, so
And as long as there is no contradiction in the combination of these technical features, it all should be considered as described in this specification.
Although the embodiments of the invention are described in conjunction with the attached drawings, but those skilled in the art can not depart from this hair
Various modifications and variations are made in the case where bright spirit and scope, such modifications and variations are each fallen within by appended claims
Within limited range.
Claims (9)
1. a kind of diagnosis of colorectal carcinoma marker, which is characterized in that including one in S100A9 albumen and tenascin-c albumen
Kind or two kinds and CEA albumen.
2. application of the Colon and rectum diagnosis marker described in claim 1 in the testing product of preparation detection colorectal cancer.
3. a kind of testing product of colorectal cancer, which is characterized in that including Colon and rectum diagnosis marker described in claim 1.
4. the testing product of colorectal cancer according to claim 3, which is characterized in that the testing product is diagnostic reagent
Box.
5. the testing product of colorectal cancer according to claim 3, which is characterized in that the testing product is for distinguishing extremely
The serum of few colorectal cancer patients and the serum of at least one non-colorectal cancer patients and/or the testing product are used for
The serum of at least one colorectal cancer patients and the serum of healthy individuals and/or the testing product are distinguished for distinguishing
The serum of at least one colorectal cancer patients and the serum of at least one patients of ulcerative colitis.
6. the testing product of colorectal cancer according to claim 5, which is characterized in that the testing product further includes being used for
Distinguish the first regression model of the serum of at least one colorectal cancer patients and the serum of at least one non-colorectal cancer patients, institute
Stating the first regression model and establishing the identification function of P is P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*
Z)] }, P value critical value is 0.62;
And/or the testing product further includes for distinguishing the serum of at least one colorectal cancer patients and at least one health
Individual serum the second regression model, second regression model establish P identification function be P=1/ 1+exp [- (-
3.7801+0.22*X+0.17*Y+0.5*Z)], wherein P value critical value is 0.71;
And/or the testing product further includes for distinguishing the serum of at least one colorectal cancer patients and at least one ulcer
Property colitis disease serum third regression model, the third regression model establish P identification function be P=1/ { 1+
Exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein P value critical value is 0.67;
Wherein, X is the concentration of CEA albumen, unit ng/mL;Y is the concentration of S100A9 albumen, unit ng/mL;Z is
The concentration of tenascin-c albumen, unit ng/mL.
7. the testing product of colorectal cancer according to claim 3, which is characterized in that it further include computer readable carrier,
Program is recorded in the computer readable carrier, when the computer readable carrier is executed by processor, realizes following step
It is rapid:
The concentration of CEA albumen in interpretation person under test's peripheral blood blood plasma, the concentration of S100A9 albumen and tenascin-c albumen it is dense
Degree;
The concentration importing of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen is sentenced
Other functional expression P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein P value critical value is 0.62;
And/or by the concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
It imports identification function P=1/ { 1+exp [- (- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein P value critical value is
0.71;
And/or by the concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
It imports identification function P=1/ { 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein P value critical value is
0.67;
Wherein, X is the concentration of CEA albumen, unit ng/mL;Y is the concentration of S100A9 albumen, unit ng/mL;Z is
The concentration of tenascin-c albumen, unit ng/mL.
8. the product for detecting S100A9 albumen and/or the product for detecting tenascin-c albumen are in preparation for assisting
Diagnose the application in the product of colorectal cancer.
9. one of the product for detecting tenascin-c albumen and/or the product for detecting S100A9 albumen or two
Kind and the product for detecting CEA albumen and computer readable carrier are in the product of preparation auxiliary diagnosis colorectal cancer
Using, wherein program is recorded in the computer readable carrier, when the computer readable carrier is executed by processor,
It performs the steps of
The concentration of CEA albumen in interpretation person under test's peripheral blood blood plasma, the concentration of S100A9 albumen and tenascin-c albumen it is dense
Degree;
The concentration importing of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen is sentenced
Other functional expression P=1/ { 1+exp [- (- 4.3762+0.3*X+0.16*Y+0.46*Z)] }, wherein P value critical value is 0.62;
And/or by the concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
It imports identification function P=1/ { 1+exp [- (- 3.7801+0.22*X+0.17*Y+0.5*Z)] }, wherein P value critical value is
0.71;
And/or by the concentration of the concentration of the CEA albumen, the concentration of the S100A9 albumen and the tenascin-c albumen
It imports identification function P=1/ { 1+exp [- (- 3.61+0.42*X+0.15*Y+0.42*Z)] }, wherein P value critical value is
0.67;Wherein, X is the concentration of CEA albumen, unit ng/mL;Y is the concentration of S100A9 albumen, unit ng/mL;Z is
The concentration of tenascin-c albumen, unit ng/mL.
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CN114758719A (en) * | 2022-06-10 | 2022-07-15 | 杭州凯莱谱精准医疗检测技术有限公司 | Colorectal cancer prediction system and application thereof |
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