MD890Z - Method for predicting the risk of development of mammary gland dyshormonal hyperplasia - Google Patents
Method for predicting the risk of development of mammary gland dyshormonal hyperplasia Download PDFInfo
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- MD890Z MD890Z MDS20140077A MDS20140077A MD890Z MD 890 Z MD890 Z MD 890Z MD S20140077 A MDS20140077 A MD S20140077A MD S20140077 A MDS20140077 A MD S20140077A MD 890 Z MD890 Z MD 890Z
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- risk
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- mammary gland
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- 238000000034 method Methods 0.000 title claims abstract description 17
- 210000005075 mammary gland Anatomy 0.000 title claims description 25
- 206010020718 hyperplasia Diseases 0.000 title claims description 21
- 239000012634 fragment Substances 0.000 claims abstract description 9
- 210000004369 blood Anatomy 0.000 claims abstract description 5
- 239000008280 blood Substances 0.000 claims abstract description 5
- 210000002381 plasma Anatomy 0.000 claims description 4
- 238000003127 radioimmunoassay Methods 0.000 claims description 3
- 102100033420 Keratin, type I cytoskeletal 19 Human genes 0.000 claims description 2
- 108010066302 Keratin-19 Proteins 0.000 claims description 2
- 108010036226 antigen CYFRA21.1 Proteins 0.000 abstract description 8
- 108010076876 Keratins Proteins 0.000 abstract description 7
- 102000011782 Keratins Human genes 0.000 abstract description 7
- 239000003814 drug Substances 0.000 abstract description 2
- 206010006256 Breast hyperplasia Diseases 0.000 abstract 2
- 230000007170 pathology Effects 0.000 description 10
- 239000003550 marker Substances 0.000 description 9
- HVDGDHBAMCBBLR-UHFFFAOYSA-N Enterolactone Natural products OC1=CC=CC(CC2C(C(=O)OC2)CC=2C=C(O)C=CC=2)=C1 HVDGDHBAMCBBLR-UHFFFAOYSA-N 0.000 description 8
- HVDGDHBAMCBBLR-WMLDXEAASA-N enterolactone Chemical compound OC1=CC=CC(C[C@@H]2[C@H](C(=O)OC2)CC=2C=C(O)C=CC=2)=C1 HVDGDHBAMCBBLR-WMLDXEAASA-N 0.000 description 8
- 230000018109 developmental process Effects 0.000 description 7
- 206010006187 Breast cancer Diseases 0.000 description 4
- 208000026310 Breast neoplasm Diseases 0.000 description 4
- 238000004393 prognosis Methods 0.000 description 4
- 101150009046 Tnfrsf1a gene Proteins 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 238000011835 investigation Methods 0.000 description 3
- 206010058314 Dysplasia Diseases 0.000 description 2
- 108010008707 Mucin-1 Proteins 0.000 description 2
- 102000007298 Mucin-1 Human genes 0.000 description 2
- 206010000210 abortion Diseases 0.000 description 2
- 231100000176 abortion Toxicity 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 230000005923 long-lasting effect Effects 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- DNXHEGUUPJUMQT-UHFFFAOYSA-N (+)-estrone Natural products OC1=CC=C2C3CCC(C)(C(CC4)=O)C4C3CCC2=C1 DNXHEGUUPJUMQT-UHFFFAOYSA-N 0.000 description 1
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 description 1
- 206010063057 Cystitis noninfective Diseases 0.000 description 1
- DNXHEGUUPJUMQT-CBZIJGRNSA-N Estrone Chemical compound OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 DNXHEGUUPJUMQT-CBZIJGRNSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 206010037596 Pyelonephritis Diseases 0.000 description 1
- 108060008683 Tumor Necrosis Factor Receptor Proteins 0.000 description 1
- 206010046914 Vaginal infection Diseases 0.000 description 1
- 201000003947 acalculous cholecystitis Diseases 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 201000001352 cholecystitis Diseases 0.000 description 1
- 201000003139 chronic cystitis Diseases 0.000 description 1
- 229960005309 estradiol Drugs 0.000 description 1
- 229930182833 estradiol Natural products 0.000 description 1
- 229960003399 estrone Drugs 0.000 description 1
- 230000005713 exacerbation Effects 0.000 description 1
- 210000000232 gallbladder Anatomy 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 201000003159 intraductal papilloma Diseases 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 208000004396 mastitis Diseases 0.000 description 1
- 230000009247 menarche Effects 0.000 description 1
- 230000002175 menstrual effect Effects 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 210000001672 ovary Anatomy 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 230000001850 reproductive effect Effects 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 201000002243 skin lipoma Diseases 0.000 description 1
- 206010043688 thyroid adenoma Diseases 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
Изобретение относится к медицине, в частности к маммологии, и может быть использовано для прогнозирования риска развития дисгормональной гиперплазии молочной железы.Согласно изобретению, заявленный метод состоит в том, что забирают 1,0 мл крови, отделяют плазму и посредством радиоимунного метода определяют количество фрагментов цитокератина 19 (Cyfra 21-1), в случае, когда количество варьирует в интервале 1,7…2,4 нг/мл, прогнозируют повышенный риск, в интервале 1,2…1,6 нг/мл - средний риск и в интервале 0,7…1,1 нг/мл - минимальный риск развития дисгормональной гиперплазии молочной железы.The invention relates to medicine, in particular to mammology, and can be used to predict the risk of developing dishormonal breast hyperplasia. According to the invention, the claimed method consists in taking 1.0 ml of blood, separating the plasma and determining the number of cytokeratin fragments using the radio-immune method. 19 (Cyfra 21-1), in the case when the amount varies in the range of 1.7 ... 2.4 ng / ml, an increased risk is predicted, in the range of 1.2 ... 1.6 ng / ml - an average risk and in the range of 0 , 7 ... 1.1 ng / ml - the minimum risk of developing dishormo breast hyperplasia.
Description
Invenţia se referă la medicină, în special la mamologie, şi poate fi utilizată pentru pronosticul riscului dezvoltării hiperplaziei dishormonale a glandei mamare. The invention relates to medicine, in particular to mammology, and can be used for the prognosis of the risk of developing dyshormonal hyperplasia of the mammary gland.
Este cunoscută metoda de pronostic al riscului dezvoltării cancerului glandei mamare, care constă în aceea că în urină se determină concentraţia sumară a estronei şi estradiolului şi dacă se obţine valoarea de 1,68 nmoli/zi se constată lipsa dezvoltării cancerului glandei mamare, iar dacă se obţin valori mai mici se constată un risc sporit de dezvoltare a cancerului glandei mamare [1]. There is a known method for predicting the risk of developing breast cancer, which consists in determining the total concentration of estrone and estradiol in urine and if the value of 1.68 nmol/day is obtained, the lack of breast cancer development is noted, and if lower values are obtained, an increased risk of developing breast cancer is noted [1].
Dezavantajul acestei metode constă în aceea că este de lungă durată, adică pe parcursul a 24 ore se colectează urina şi pentru pronosticul cancerului glandei mamare se efectuează evidenţierea şi calculul a doi markeri. The disadvantage of this method is that it is long-lasting, meaning that urine is collected over 24 hours and two markers are identified and calculated for the prognosis of breast cancer.
Mai este cunoscută o metodă de determinare a riscului dezvoltării displaziei benigne a glandei mamare, care constă în evidenţierea din sângele periferic a ADN-ului şi determinarea polimorfismului genei receptor a factorului de necroză de primul tip (+36 AG TNFR 1), în cazul în care se determină genotipurile AA TNFR 1 şi 36 AG TNFR 1 se pronostichează un risc sporit de dezvoltare a displaziei benigne a glandei mamare [2]. There is also a known method for determining the risk of developing benign dysplasia of the mammary gland, which consists of identifying DNA from peripheral blood and determining the polymorphism of the tumor necrosis factor receptor gene of the first type (+36 AG TNFR 1), if the AA TNFR 1 and 36 AG TNFR 1 genotypes are determined, an increased risk of developing benign dysplasia of the mammary gland is predicted [2].
Dezavantajul acestei metode constă în aceea că este tehnologic complicată, de lungă durată (8…10 ore) şi costisitoare. The disadvantage of this method is that it is technologically complicated, long-lasting (8…10 hours) and expensive.
În calitate de cea mai apropiată soluţie este cunoscută metoda de pronostic al riscului apariţiei hiperplaziei dishormonale a glandei mamare, care constă în aceea că se recoltează sânge de la pacientă, se separă plasma sangvină, se determină concentraţia enterolactonei în ea şi dacă aceasta este de 13…30 nmoli/L se pronostichează un risc major de apariţie a hiperplaziei dishormonale, de 30…70 nmol/L - un risc mediu şi de 70…118 nmoli/L - un risc minor de apariţie a hiperplaziei dishormonale a glandei mamare [3]. As the closest solution, the method of predicting the risk of developing dyshormonal hyperplasia of the mammary gland is known, which consists in collecting blood from the patient, separating the blood plasma, determining the concentration of enterolactone in it and if it is 13…30 nmol/L, a major risk of developing dyshormonal hyperplasia is predicted, 30…70 nmol/L - a medium risk and 70…118 nmol/L - a minor risk of developing dyshormonal hyperplasia of the mammary gland [3].
Dezavantajul acestei metode constă în aceea că se determină riscul de apariţie a hiperplaziei dishormonale a glandei mamare numai la pacientele ce suferă de maladii ginecologice, la fel pronosticul se face când sunt indicaţii directe la dezvoltarea hiperplaziei glandei mamare, deci patologia se face deja aparentă. The disadvantage of this method is that the risk of developing dyshormonal hyperplasia of the mammary gland is determined only in patients suffering from gynecological diseases, and the prognosis is made when there are direct indications for the development of mammary gland hyperplasia, so the pathology is already apparent.
Problema pe care o soluţionează invenţia constă în elaborarea unei metode de determinare precoce a riscului de dezvoltare a hiperplaziei glandei mamare la orice femeie care suferă sau nu de o patologie ginecologică, sau are vreo patologie a sânului. The problem solved by the invention consists in developing a method for early determination of the risk of developing mammary gland hyperplasia in any woman who suffers or not from a gynecological pathology, or has any breast pathology.
Conform invenţiei, metoda revendicată constă în aceea că se recoltează 1,0 ml de sânge, se separă plasma şi prin metoda radioimună se determină cantitatea de fragmente ale citokeratinei 19 (Cyfra 21-1), în cazul în care cantitatea variază în intervalul 1,7…2,4 ng/ml se pronostichează un risc major de dezvoltare, în intervalul 1,2…1,6 ng/ml - un risc mediu şi în intervalul 0,7…1,1 ng/ml - un risc minor de dezvoltare a hiperplaziei dishormonale a glandei mamare. According to the invention, the claimed method consists in collecting 1.0 ml of blood, separating the plasma and determining the amount of cytokeratin 19 fragments (Cyfra 21-1) by radioimmunoassay. If the amount varies in the range of 1.7…2.4 ng/ml, a major risk of development is predicted, in the range of 1.2…1.6 ng/ml - a medium risk and in the range of 0.7…1.1 ng/ml - a minor risk of development of dyshormonal hyperplasia of the mammary gland.
În urma investigaţiilor efectuate pe un lot de 200 de paciente s-a determinat o anumită legitate: în cazul determinării markerului fragmentului 19 al citokeratinei (Cyfra 21-1), care de fapt este un oncomarker specific pentru dezvoltarea proceselor în vezica urinară, se determinau pe viitor, undeva peste 2…3 luni, şi procese de dezvoltare a hiperplaziei glandei mamare, adică la cele 200 de paciente li s-a determinat la început markerul fragmentului 19 al citokeratinei (Cyfra 21-1), markerul oncospecific pentru patologiile glandei mamare antigenul glucidic CA 15-3 şi enterolactona; pentru primul marker s-au obţinut valori de 0,7…2,4 ng/L, iar cel de al doilea specific era în intervalele normei fiziologice, adică 9,2…38 UI/L, la fel şi indicii enterolactonei erau în limitele normei fiziologice, apoi aceste paciente au fost investigate peste 3 luni, când deja îşi făcea apariţia şi markerul CA 15-3, înregisrându-se valori de 128…179 UI/L, iar pentru enterolactonă 13…118 nmoli/L, ulterior în baza investigaţiilor clinice şi paraclinice s-a confirmat diagnosticul de hiperplazie a glandei mamare. Pronosticarea hiperplaziei glandei mamare datorită determinării fragmentului 19 al citokeratinei (Cyfra 21-1) în serul sangvin ne permite o apreciere mai timpurie a riscului dezvoltării hiperplaziei glandei mamare. Following investigations carried out on a group of 200 patients, a certain legality was determined: in the case of determining the cytokeratin fragment 19 marker (Cyfra 21-1), which is actually a specific oncomarker for the development of processes in the urinary bladder, in the future, somewhere after 2…3 months, the development processes of mammary gland hyperplasia were also determined, that is, in the 200 patients, the cytokeratin fragment 19 marker (Cyfra 21-1), the oncospecific marker for mammary gland pathologies, the carbohydrate antigen CA 15-3, and enterolactone were initially determined; for the first marker, values of 0.7…2.4 ng/L were obtained, and the second specific one was within the physiological norm, i.e. 9.2…38 IU/L, as well as the enterolactone indices were within the physiological norm, then these patients were investigated after 3 months, when the CA 15-3 marker was already appearing, recording values of 128…179 IU/L, and for enterolactone 13…118 nmol/L, subsequently, based on clinical and paraclinical investigations, the diagnosis of mammary gland hyperplasia was confirmed. The prognosis of mammary gland hyperplasia due to the determination of cytokeratin fragment 19 (Cyfra 21-1) in blood serum allows us to assess the risk of developing mammary gland hyperplasia earlier.
Metoda se efectuează în modul următor. De la pacientele cu sau fără diferite maladii se recoltează 1,0 ml de sânge, se separă plasma sangvină, se determină după metoda radioimună cantitatea fragmentului 19 al citokeratinei (Cyfra 21-1) şi în cazul în care se stabilesc valori de 0,7…2,4 ng/L se pronostichează un risc de dezvoltare a hiperplaziei glandei mamare, iar în dependenţă de cantitate se poate stabili şi gradul de dezvoltare a riscului, adică dacă se determină valorile fragmentului 19 al citokeratinei (Cyfra 21-1) în intervalul de 1,7…2,4 ng/L se pronostichează un risc major de apariţie a hiperplaziei dishormonale, în intervalul 1,2…1,6 ng/L - un risc mediu şi în intervalul 0,7…1,1 ng/L - un risc minor de apariţie a hiperplaziei dishormonale a glandei mamare. The method is performed as follows. From patients with or without various diseases, 1.0 ml of blood is collected, the blood plasma is separated, the amount of cytokeratin fragment 19 (Cyfra 21-1) is determined by the radioimmunoassay method, and if values of 0.7…2.4 ng/L are established, a risk of developing mammary gland hyperplasia is predicted, and depending on the quantity, the degree of risk development can also be established, i.e. if the values of cytokeratin fragment 19 (Cyfra 21-1) are determined in the range of 1.7…2.4 ng/L, a major risk of developing dyshormonal hyperplasia is predicted, in the range of 1.2…1.6 ng/L - an average risk, and in the range of 0.7…1.1 ng/L - a minor risk of developing dyshormonal hyperplasia of the mammary gland.
Avantajul metodei revendicate constă în aceea că mult mai precoce se poate pronostica riscul dezvoltării hiperplaziei glandei mamare, adică în medie cu 3 luni mai precoce. The advantage of the claimed method is that the risk of developing mammary gland hyperplasia can be predicted much earlier, i.e. on average 3 months earlier.
Exemplu Example
Pacienta M., 39 ani, căsătorită de 19 ani, de varstă reproductivă, prima menarhă la 13 ani, durata menstruaţiei 3…4 zile, ritmul menstrual regulat, relaţii sexuale pană la 20 de ani nu au fost, avort precedent maladiei - absent, 1 naştere, avorturi - 1, cancer la rude - absent, mastită - absent, trauma glandei mamare - absent, papilom intraductal - absent, FAM - absent, pielea - lipom, glanda tiroidă - fără patologie, patologie ginecologică - colpită. Patologie urogenitală - cistită cronică în acutizare. S-a determinat la început markerul fragmentului 19 al citokeratinei (Cyfra 21-1), markerul oncospecific pentru patologiile glandei mamare antigenul glucidic CA 15-3 şi enterolactona, rezultatul obţinut pentru primul marker era de 1,3 ng/L, iar cel de al doilea specific era în intervalele normei fiziologice, adică 14 UI/L, la fel şi indicii enterolactonei erau în limitele normei fiziologice, apoi această pacientă a fost investigată peste 3 luni, când deja îşi făcea apariţia şi markerul CA 15-3, înregistrându-se o valoare de 139 UI/L, iar pentru enterolactonă - 78 nmoli/L, ulterior în baza investigaţiilor clinice şi paraclinice s-a confirmat diagnosticul de hiperplazie a glandei mamare. La USG glandei tiroide - adenom, glanda mamară - fără patologie, ficatul - fără schimbări, pancreasul - pancreatită cronică reactivă, vezica biliară - colecistită cronică acalculoasă, rinichii - pielonefrită, ovarele - fără patologii. Concentraţia de enterolactonă - 13 ng/L. Deci la pacienta dată s-a stabilit riscul mediu de dezvoltare a hiperplaziei dishormonale a glandei mamare. Patient M., 39 years old, married for 19 years, of reproductive age, first menarche at 13 years old, duration of menstruation 3…4 days, regular menstrual rhythm, no sexual intercourse up to 20 years old, abortion preceding the disease - absent, 1 birth, abortions - 1, cancer in relatives - absent, mastitis - absent, mammary gland trauma - absent, intraductal papilloma - absent, FAM - absent, skin - lipoma, thyroid gland - no pathology, gynecological pathology - colpitis. Urogenital pathology - chronic cystitis in exacerbation. At first, the cytokeratin fragment 19 marker (Cyfra 21-1), the oncospecific marker for mammary gland pathologies, the carbohydrate antigen CA 15-3, and enterolactone were determined. The result obtained for the first marker was 1.3 ng/L, and the second specific one was within the physiological norm, i.e. 14 IU/L. The enterolactone indices were also within the physiological norm. Then this patient was investigated after 3 months, when the CA 15-3 marker also appeared, recording a value of 139 IU/L, and for enterolactone - 78 nmol/L. Subsequently, based on clinical and paraclinical investigations, the diagnosis of mammary gland hyperplasia was confirmed. On USG of the thyroid gland - adenoma, mammary gland - no pathology, liver - no changes, pancreas - chronic reactive pancreatitis, gallbladder - chronic acalculous cholecystitis, kidneys - pyelonephritis, ovaries - no pathologies. Enterolactone concentration - 13 ng/L. So in this patient the average risk of developing dyshormonal hyperplasia of the mammary gland was established.
1. RU 2263319 C2 2005.10.27 1. RU 2263319 C2 2005.10.27
2. RU 2480763 C1 2013.03.07 2. RU 2480763 C1 2013.03.07
3. MD 2872 F1 2005.10.31 3. MD 2872 F1 2005.10.31
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| MDS20140077A MD890Z (en) | 2014-05-30 | 2014-05-30 | Method for predicting the risk of development of mammary gland dyshormonal hyperplasia |
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| MD890Z true MD890Z (en) | 2015-10-31 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD1119Z (en) * | 2016-05-06 | 2017-09-30 | Оксана ОДОБЕСКУ | Method for predicting the risk of malignization of phylloid mammary gland tumor |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2263319C2 (en) * | 2003-07-31 | 2005-10-27 | Ростовский научно-исследовательский онкологический институт МЗ РФ | Method for predicting relapse of mammary cancer |
| MD2872F1 (en) * | 2005-03-04 | 2005-10-31 | Mihail SURGUCI | Method of prognosticating the risk of appearance of the mammary dyshormonal hyperplasia |
| RU2480763C1 (en) * | 2012-03-07 | 2013-04-27 | Федеральное государственное автономное образовательное учреждение высшего профессионального образования "Белгородский государственный национальный исследовательский университет" | Method for prediction of risk of developing benign mammry dysplasia in females with genital endometriosis |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2263319C2 (en) * | 2003-07-31 | 2005-10-27 | Ростовский научно-исследовательский онкологический институт МЗ РФ | Method for predicting relapse of mammary cancer |
| MD2872F1 (en) * | 2005-03-04 | 2005-10-31 | Mihail SURGUCI | Method of prognosticating the risk of appearance of the mammary dyshormonal hyperplasia |
| RU2480763C1 (en) * | 2012-03-07 | 2013-04-27 | Федеральное государственное автономное образовательное учреждение высшего профессионального образования "Белгородский государственный национальный исследовательский университет" | Method for prediction of risk of developing benign mammry dysplasia in females with genital endometriosis |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD1119Z (en) * | 2016-05-06 | 2017-09-30 | Оксана ОДОБЕСКУ | Method for predicting the risk of malignization of phylloid mammary gland tumor |
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