CN105717146B - A kind of cancer risk assessment kit being directed to Chinese city population people at highest risk based on CT images and biomarker spectrum - Google Patents
A kind of cancer risk assessment kit being directed to Chinese city population people at highest risk based on CT images and biomarker spectrum Download PDFInfo
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Abstract
The present invention relates to a kind of cancer risk assessment kits being directed to Chinese city population people at highest risk based on CT images and biomarker spectrum.The kit includes measuring the reagent of following four biomarker Serum protein expression quantity：Gastrin discharges propetide, carcinomebryonic antigen, the segment of Cyfra21-1 and squamous cell carcinoma antigen.It is combined with CT images parameter tubercle diameter, spicule sign, position and other clinical indices ages, smoking history, malignant tumour history, gender, can be used for Accurate Prediction lung-cancer-risk.
Description
Technical field
The present invention relates to medical biotechnology fields, are composed based on CT images and biomarker specifically, being related to one kind
For the cancer risk assessment kit of Chinese city population people at highest risk.
Background technology
Lung cancer is common in world wide and is the highest cancer of lethality.In China, lung cancer morbidity rate and the death rate
It is in first of each malignant tumour.According to world institute of oncology of the World Health Organization (The International Agency
For Research on Cancer, IARC) statistics, China's lung cancer morbidity rate in 2008 is 35/,100,000 people, and the mechanism is estimated
For meter to 2025, China will increase lung cancer 1,000,000 newly every year.According to the Ministry of Public Health of China health statistics yearbook in 2010, cut-off
2009, national lung cancer mortality was 30.83/10 ten thousand people, and the liver cancer higher than the second high mortality exceedes 4/,100,000 people.Although lung cancer
5 years survival rates there was only 15%, but it is that the patient of lung cancer its 5 years survival rates can reach 49% to account for 16% early diagnosis, it is seen that
Early diagnosis is an important factor for improving patients with lung cancer survival rate.
With increasing, the increasingly exacerbation of environmental pollution of urban population, lung cancer is notable in the incidence of urban population
Higher than rural area.Currently, with the extensive screening for carrying out lung cancer by low-dose CT in people at highest risk, more and more
Early stage of lung cancer patient is had found in time, and significantly reduces the death rate caused by lung cancer.CT images technology is in High Risk of Lung Cancer people
Screening lung cancer has the advantages that hypersensitivity in group, but its limitation is that specificity is relatively not high enough, i.e. screening goes out most of
Lung neoplasm may be benign protuberance, and this not only adds the economic expenditures of social screening lung cancer, while also increasing the heart of patient
Reason burden.It finds in our study, by the conjunctive use of one group of specific biomarker spectrum, morning can be significantly improved
The specificity of phase pulmonary cancer diagnosis to make up the low limitation of CT screenings lung cancer specificity, while having higher sensibility.Mesh
The preceding cancer risk assessment model invented in the world for American-European crowd, and still for the high risk model of Chinese population
It has no and has been reported that.
Invention content
The purpose of the present invention is being directed to deficiency in the prior art, the composition for predicting lung-cancer-risk is provided.
Another purpose of the present invention is to provide the purposes of the composition.
Another purpose of the present invention is to provide a kind of kit for predicting lung-cancer-risk.
To realize above-mentioned first purpose, the technical solution adopted by the present invention is that：
A kind of composition for predicting lung-cancer-risk, including measure the expression of following four biomarker Serum protein
The reagent of amount：Gastrin discharges propetide, carcinomebryonic antigen, the segment of Cyfra21-1 and squamous cell carcinoma antigen.
Preferably, including following reagent：Four kinds of biomarkers and its enzyme labelled antibody, the carbonate buffer that pH value is 9.6
Liquid, the phosphate buffer that pH value is 7.4, haemocyanin dilution, terminate liquid, tetramethyl benzidine substrates solution.
It is highly preferred that further including following reagent：Normal human serum and positive control serum.
To realize above-mentioned second purpose, the technical solution adopted by the present invention is that：
As above application of any composition in the kit for preparing prediction lung-cancer-risk.
The prediction lung-cancer-risk is directed to Chinese city population.
To realize above-mentioned third purpose, the technical solution adopted by the present invention is that：
A kind of kit for predicting lung-cancer-risk, including measure the expression of following four biomarker Serum protein
The reagent of amount：Gastrin discharges propetide, carcinomebryonic antigen, the segment of Cyfra21-1 and squamous cell carcinoma antigen.
Preferably, the kit further includes the carrier recorded such as drag and evaluation method：
Pernicious probability=ex/(1+ex)
Wherein, X=-0.5875+ (0.00848 × age)+(5.103 × smoking history)+(- 2.8926 × malignant tumour history)
+ (0.1216 × tubercle diameter)+(3.3835 × spicule sign)+(- 4.0907 × position)+(- 5.1276 × gender)+(-
0.00023×ProGRP)+(0.0362×SCC-Ag)+(0.1477×CYFRA21-1)+(-0.00256×CEA)
Previously there are smoking history, smoking=1, the past non-smoking history, smoking=0；Previously there are malignant tumour history, malignant tumour history
=1, previously without malignant tumour history, malignant tumour history=0；Jagged sign, spicule sign=1, impulse- free robustness sign, spicule sign=0；It is located at
Upper leaf, position=1 are located at non-upper leaf, position=0；Gender is male, and gender=1, gender is women, gender=0.
Tubercle diameter (mm), spicule sign, position are analysed all in accordance with CT images credit and are obtained.
It is low danger when pernicious probability≤0.13；When pernicious probability>It is middle danger when 0.13 and≤0.68；And when pernicious general
Rate>It is high-risk when 0.68.
Preferably, the kit includes following reagent：Four kinds of biomarkers and its enzyme labelled antibody, pH value 9.6
Carbonate buffer solution, pH value be 7.4 phosphate buffer, haemocyanin dilution, terminate liquid, tetramethyl benzidine substrates
Solution.
It is highly preferred that the kit further includes following reagent：Normal human serum and positive control serum.
Herein, according to《The Chinese Consensus of experts of primary bronchogenic carcinoma of lung early diagnosis》In definition, Chinese city people
Mouthful people at highest risk, which is defined as living in Chinese city, has the crowd of following High Risk of Lung Cancer factor：55~80 years old age；Smoking refers to
>=400 years branch (or 20 packet years) of number；High-risk Exposed history；There are malignant tumour medical history or lung cancer family history；There is chronic obstructive pulmonary disease, diffuse
Property pulmonary fibrosis and pulmonary tuberculosis medical history.
The invention has the advantages that：
1, present invention firstly provides the segments and squamous that include gastrin release propetide, carcinomebryonic antigen, Cyfra21-1
4 kinds of biomarkers including cell carcinoma antigen are combined with CT images parameter and other clinical indices can become screening lung cancer
Leading indicator.
2, including gastrin release propetide, carcinomebryonic antigen, the segment of Cyfra21-1 and squamous cell carcinoma antigen
4 kinds of biomarkers combined with CT images parameter and other clinical indices as prediction index compared with currently used for screening lung cancer
Low dosage chest CT index and other clinical indices it is more objective, and measure such biomarker expression it is horizontal it is simple,
It is easy, reliable.
3, disclosure is particularly well suited to the cancer risk assessments of Chinese city population people at highest risk.
Description of the drawings
Fig. 1 is the cancer risk assessment model ROC curve composed based on CT images and biomarker to people at highest risk.
Specific implementation mode
It elaborates below in conjunction with the accompanying drawings to specific implementation mode provided by the invention.
Embodiment 1
The composition of kit of the present invention：
By biomarker and its enzyme labelled antibody, the carbonate buffer solution that pH value is 9.6, the phosphate that pH value is 7.4 delays
Fliud flushing, haemocyanin dilution, terminate liquid, tetramethyl benzidine substrates solution, normal human serum and positive control serum composition.
The biomarker includes the segment and squamous of gastrin release propetide, carcinomebryonic antigen, Cyfra21-1
Cell carcinoma antigen；The carbonate buffer solution that the pH value is 9.6 is that 1.59 grams of sodium carbonate and 2.93 grams of sodium bicarbonates are added to 1L
It is obtained in distilled water；The phosphate buffer that the pH value is 7.4 is by 0.2 gram of potassium dihydrogen phosphate, 2.9 gram of 12 hypophosphite monohydrate
Disodium hydrogen, 8.0 grams of sodium chloride, 0.2 gram of potassium chloride, 0.5mL Tween-20s are added in 1L distilled water and are obtained；The haemocyanin
Dilution is that 0.1 gram of cow's serum, sheep blood serum or rabbit serum proteins add to 100mL pH value and obtained for 7.4 phosphate buffer；
The terminate liquid is 2M sulfuric acid solutions；The tetramethyl benzidine substrates solution is the tetramethyl of a concentration of 2mg/mL of 0.5mL
The ethanol solution of base benzidine, the peroxide for the substrate buffer solution and 32 a concentration of 0.75vol% of μ L that 10mL pH value is 5.0
Change aqueous solution of hydrogen to be obtained by mixing, the substrate buffer solution that the pH value is 5.0 is disodium hydrogen phosphate containing 0.2M and 0.1M citric acids
Distilled water solution.
The application method of kit of the present invention：
1, it is coated with：Biomarker is diluted to protein content by the carbonate buffer solution for being 9.6 with 0.05M pH value
1-10μg/mL.Add 0.1mL in the reacting hole of each polystyrene, overnight in 4 DEG C.Next day discards solution in hole, uses pH value
It is washed 3 times, every time 3 minutes for 7.4 phosphate buffer.
2, it is loaded：Respectively plus measuring samples, normal human serum and positive control after certain haemocyanin diluted
In serum 0.1mL to above-mentioned coated reacting hole, set 37 DEG C be incubated 1 hour after with pH value be 7.4 phosphate buffer wash 3
It is secondary, 3 minutes every time.
3, add horseradish peroxidase labeling antibody：The horseradish peroxidase mark that diluted fresh is added in each reacting hole is anti-
Body 0.1mL, 37 DEG C be incubated 0.5-1 hour after washed 3 times, every time 3 minutes for 7.4 phosphate buffer with pH value.
4, plus substrate solution develops the color：Tetramethyl benzidine substrates solution 0.1mL is added in each reacting hole, is incubated at 37 DEG C
10-30 minutes.
5, reaction is terminated：2M sulfuric acid 0.05mL is added in each reacting hole.
6, result judgement：On ELISA detectors, at 450nm, each hole OD values are surveyed after returning to zero with blank control wells.If
It is as positive more than 2.1 times of defined negative control OD value.
Using normal control product protein expression level as measurement standard, Serum of Patients with Lung Cancer proteinogram expression quantity divided by this mark
Standard calculates pernicious so that it is determined that expression ratio of patient's proteinogram relative to normal person, ratio is substituted into respectively in following formula
Risk probability.
Pernicious probability=ex/(1+ex)
X=-0.5875+ (0.00848 × age)+(5.103 × smoking history)+(- 2.8926 × malignant tumour history)+
(0.1216 × tubercle diameter)+(3.3835 × spicule sign)+(- 4.0907 × position)+(- 5.1276 × gender+(- 0.00023
×ProGRP)+(0.0362×SCC-Ag)+(0.1477×CYFRA 21-1)+(-0.00256×CEA)
It is low danger when pernicious probability≤0.13；When pernicious probability>It is middle danger when 0.13 and≤0.68；And when pernicious general
Rate>It is high-risk when 0.68.
The model sensibility is 91.9%, and specificity is 95.3%.
Previously there are smoking history, smoking=1, the past non-smoking history, smoking=0；Previously there are malignant tumour history, malignant tumour history
=1, previously without malignant tumour history, malignant tumour history=0；Jagged sign, spicule sign=1, impulse- free robustness sign, spicule sign=0；It is located at
Upper leaf, position=1 are located at non-upper leaf, position=0；Gender is male, and gender=1, gender is women, gender=0.
Tubercle diameter (mm), spicule sign, position are analysed all in accordance with CT images credit and are obtained.
Embodiment 2
The present invention determines 454 patients of urban population for having High Risk of Lung Cancer factor by collecting by clinical, eventually by
Definitive pathological diagnosis lung cancer 285 has been sampled 111 Serum of Patients with Lung Cancer by method of randomization；Simultaneously 169 non-lung cancer persons'
In Serum Bank, pass through method of randomization 129 normal human serums of sampling.The sub- immunodetection of applied chemistry luminous particle detects blood
4 kinds of biomarkers in clear, while acquiring the clinical information such as patient age, smoking history, tubercle diameter, spicule sign, gender.It obtains
Model sensitivity and specificity is as shown in table 1.The cancer risk assessment to people at highest risk is composed based on CT images and biomarker
Model ROC curve is as shown in Figure 1.
Table 1 has the cancer risk assessment model of Chinese urban population people at highest risk based on CT images and biomarker spectrum
Effect property
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
Member, under the premise of not departing from the method for the present invention, can also make several improvement and supplement, these are improved and supplement also should be regarded as
Protection scope of the present invention.
Claims (3)
1. a kind of kit for predicting lung-cancer-risk, which is characterized in that including measuring following four biomarker serum
The reagent of proteinogram expression quantity：It is anti-that gastrin discharges propetide, carcinomebryonic antigen, the segment of Cyfra21-1 and squamous cell carcinoma
It is former；The kit further includes the carrier recorded such as drag and evaluation method：
Pernicious probability=ex/(1+ex)
Wherein, X=-0.5875+ (0.00848 × age)+(5.103 × smoking history)+(- 2.8926 × malignant tumour history)+
(0.1216 × tubercle diameter)+(3.3835 × spicule sign)+(- 4.0907 × position)+(- 5.1276 × gender)+(- 0.00023
×ProGRP)+(0.0362×SCC-Ag)+(0.1477×CYFRA21-1)+(-0.00256×CEA)
Previously there are smoking history, smoking=1, the past non-smoking history, smoking=0；Previously there is a malignant tumour history, malignant tumour history=1,
Previously without malignant tumour history, malignant tumour history=0；Jagged sign, spicule sign=1, impulse- free robustness sign, spicule sign=0；Positioned at upper
Leaf, position=1 are located at non-upper leaf, position=0；Gender is male, and gender=1, gender is women, gender=0；
Tubercle diameter (mm), spicule sign, position are analysed all in accordance with CT images credit and are obtained；
It is low danger when pernicious probability≤0.13；When pernicious probability>It is middle danger when 0.13 and≤0.68；And work as pernicious probability>
It is high-risk when 0.68.
2. kit according to claim 1, which is characterized in that including following reagent：Four kinds of biomarkers and its enzyme
Labeling antibody, the carbonate buffer solution that pH value is 9.6, the phosphate buffer that pH value is 7.4, haemocyanin dilution, terminate liquid,
Tetramethyl benzidine substrates solution.
3. kit according to claim 2, which is characterized in that further include following reagent：Normal human serum and the positive are right
According to serum.
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| CN117368475A (en) * | 2017-02-09 | 2024-01-09 | 得克萨斯大学体系董事会 | Method for detecting and treating lung cancer |
| CN106943192A (en) * | 2017-03-14 | 2017-07-14 | 上海交通大学医学院附属第九人民医院 | The method for building up of the preoperative forecast model of the expression index of lung carcinoma cell KI 67 |
| CN107292114B (en) * | 2017-06-28 | 2020-07-14 | 中日友好医院 | Establishing method of solitary pulmonary nodule malignancy probability prediction model |
| CN110223775B (en) * | 2019-07-15 | 2021-01-01 | 四川大学华西医院 | Lung cancer risk prediction system |
| CN110223776B (en) * | 2019-07-15 | 2021-01-01 | 四川大学华西医院 | Lung cancer risk prediction system |
| CN113707224A (en) * | 2021-08-30 | 2021-11-26 | 东南大学 | Cross-scale integration assessment pulmonary nodule malignancy risk prediction system |
| WO2024046207A1 (en) * | 2022-09-01 | 2024-03-07 | 广州燃石医学检验所有限公司 | Tumor biomarker, and cancer risk information generation method and apparatus |
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