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| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
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WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-menopausal women with AUB | The patients will be divided into different study groups: "Control" and cases or "EC", the latter could be subdivided and analyzed in separate groups related to their prognosis. The "Control" patients are those patients with symptoms compatible with endometrial cancer but who are diagnosed with benign and / or healthy pathology; while "EC" patients present associated symptoms and are diagnosed with endometrial cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WomEC | Diagnostic Test | The study will collect pipelle biopsies from post-menopausal women presenting with AUB entering to the EC diagnostic process at the clinical consultancy or emergency room. In the study an endometrial biopsy by aspiration will be collected (i.e., pipelle biopsy) and it will be used for (1) diagnostic purposes following current procedures (i.e., pathological examination and diagnosis); (2) placed in a collection tube for WomEC test. |
| Measure | Description | Time Frame |
|---|---|---|
| Regulatory Requirements Study | Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test. | 12 months |
| Algorithm training with Proprietary Antibodies | Train the current WomEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination to rule out EC in post- menopausal women with AUB using MiMARK's proprietary antibodies. | 12 months |
| Algorithm testing and freeze | To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy. | Test the ability of WomEC to discriminate between EC and non-EC patients. | 12 months |
| Evaluation of the performance of different models of WomEC to determine histological subtype. |
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Inclusion Criteria:
Post-menopausal women (≥1 year without menstruation) with AUB who present with:
i. Persistent symptoms (more than one episode of metrorrhagia) ii. Heterogenous endometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.
Obtaining written informed consent
Exclusion Criteria:
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(Adult, Older Adult)
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Post-menopausal women presenting AUB entering to the EC diagnostic process at the clinical consultancy or emergency room.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gil-Moreno, MD, PhD | Hospital Universitari Campus Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Torrevieja | Torrevieja | Alicante | 03186 | Spain | ||
| Hospital Universitari Son Espases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. | |
| 35020204 | Background | Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Uterine Aspirate Samples
|
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine an histological subtype. |
| 12 months |
| Evaluation of the performance of WomEC to determine other prognostic factors of EC. | Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine other prognostic factors of EC. | 12 months |
| Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia. | Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to diagnose endometrial atypical hyperplasia. | 12 months |
| Palma de Mallorca |
| Balearic Islands |
| 07120 |
| Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Dexeus - Quirón de Barcelona | Barcelona | Barcelona | 08028 | Spain |
| Hospital Universitari Campus Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Igualada | Igualada | Barcelona | 08700 | Spain |
| Hospital Universitari de Bellvitge - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario de la Plana | Villarreal | Castellon | 12540 | Spain |
| Hospital Clínico de Santiago | A Coruña | Galicia | 15706 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Hospital Universitario de Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Materno Infantil de Gran Canaria | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Clinico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario Quirónsalud Madrid | Madrid | Madrid | 28223 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | Murcia | Spain |
| Hospital General Universitari de València | Valencia | Valencia | 46014 | Spain |
| Hospital Universitario y Politécnico de La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario de Puerto Real | Cadiz | 11510 | Spain |
| Hospital General Universitari de Castelló | Castellon | 12004 | Spain |
| Hospital Universitario de León | León | 24008 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| 29944932 | Background | Dueholm M, Hjorth IMD, Dahl K, Hansen ES, Ortoft G. Ultrasound Scoring of Endometrial Pattern for Fast-track Identification or Exclusion of Endometrial Cancer in Women with Postmenopausal Bleeding. J Minim Invasive Gynecol. 2019 Mar-Apr;26(3):516-525. doi: 10.1016/j.jmig.2018.06.010. Epub 2018 Jun 23. |
| 30083701 | Background | Clarke MA, Long BJ, Del Mar Morillo A, Arbyn M, Bakkum-Gamez JN, Wentzensen N. Association of Endometrial Cancer Risk With Postmenopausal Bleeding in Women: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Sep 1;178(9):1210-1222. doi: 10.1001/jamainternmed.2018.2820. |
| 26748390 | Background | van Hanegem N, Prins MM, Bongers MY, Opmeer BC, Sahota DS, Mol BW, Timmermans A. The accuracy of endometrial sampling in women with postmenopausal bleeding: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:147-55. doi: 10.1016/j.ejogrb.2015.12.008. Epub 2015 Dec 19. |
| 12151831 | Background | Bradley LD. Complications in hysteroscopy: prevention, treatment and legal risk. Curr Opin Obstet Gynecol. 2002 Aug;14(4):409-15. doi: 10.1097/00001703-200208000-00008. |
| 24366295 | Background | Helpman L, Kupets R, Covens A, Saad RS, Khalifa MA, Ismiil N, Ghorab Z, Dube V, Nofech-Mozes S. Assessment of endometrial sampling as a predictor of final surgical pathology in endometrial cancer. Br J Cancer. 2014 Feb 4;110(3):609-15. doi: 10.1038/bjc.2013.766. Epub 2013 Dec 24. |
| 28885397 | Background | Visser NCM, Reijnen C, Massuger LFAG, Nagtegaal ID, Bulten J, Pijnenborg JMA. Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):803-813. doi: 10.1097/AOG.0000000000002261. |
| 21207424 | Background | Colas E, Perez C, Cabrera S, Pedrola N, Monge M, Castellvi J, Eyzaguirre F, Gregorio J, Ruiz A, Llaurado M, Rigau M, Garcia M, Ertekin T, Montes M, Lopez-Lopez R, Carreras R, Xercavins J, Ortega A, Maes T, Rosell E, Doll A, Abal M, Reventos J, Gil-Moreno A. Molecular markers of endometrial carcinoma detected in uterine aspirates. Int J Cancer. 2011 Nov 15;129(10):2435-44. doi: 10.1002/ijc.25901. Epub 2011 Apr 8. |
| 23649867 | Background | Perez-Sanchez C, Colas E, Cabrera S, Falcon O, Sanchez-del-Rio A, Garcia E, Fernandez-de-Castillo L, Muruzabal JC, Alvarez E, Fiol G, Gonzalez C, Torrejon R, Moral E, Campos M, Repolles M, Carreras R, Jimenez-Lopez J, Xercavins J, Aibar E, Perdones-Montero A, Lalanne E, Palicio M, Maes T, Rosell-Vives E, Nieto C, Ortega A, Pedrola N, Llaurado M, Rigau M, Doll A, Abal M, Ponce J, Gil-Moreno A, Reventos J. Molecular diagnosis of endometrial cancer from uterine aspirates. Int J Cancer. 2013 Nov 15;133(10):2383-91. doi: 10.1002/ijc.28243. Epub 2013 Jun 21. |
| 29183259 | Background | Martinez-Garcia E, Lopez-Gil C, Campoy I, Vallve J, Coll E, Cabrera S, Ramon Y Cajal S, Matias-Guiu X, Van Oostrum J, Reventos J, Gil-Moreno A, Colas E. Advances in endometrial cancer protein biomarkers for use in the clinic. Expert Rev Proteomics. 2018 Jan;15(1):81-99. doi: 10.1080/14789450.2018.1410061. Epub 2017 Nov 30. |
| 27447978 | Background | Martinez-Garcia E, Lesur A, Devis L, Campos A, Cabrera S, van Oostrum J, Matias-Guiu X, Gil-Moreno A, Reventos J, Colas E, Domon B. Development of a sequential workflow based on LC-PRM for the verification of endometrial cancer protein biomarkers in uterine aspirate samples. Oncotarget. 2016 Aug 16;7(33):53102-53115. doi: 10.18632/oncotarget.10632. |
| 28790116 | Background | Martinez-Garcia E, Lesur A, Devis L, Cabrera S, Matias-Guiu X, Hirschfeld M, Asberger J, van Oostrum J, Casares de Cal MLA, Gomez-Tato A, Reventos J, Domon B, Colas E, Gil-Moreno A. Targeted Proteomics Identifies Proteomic Signatures in Liquid Biopsies of the Endometrium to Diagnose Endometrial Cancer and Assist in the Prediction of the Optimal Surgical Treatment. Clin Cancer Res. 2017 Nov 1;23(21):6458-6467. doi: 10.1158/1078-0432.CCR-17-0474. Epub 2017 Aug 8. |
| 3203132 | Background | DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45. |
| Background | Fawcett T. An introduction to ROC analysis. Pattern Recognit Lett. North-Holland; 2006;27:861-74. |
| 21414208 | Background | Robin X, Turck N, Hainard A, Tiberti N, Lisacek F, Sanchez JC, Muller M. pROC: an open-source package for R and S+ to analyze and compare ROC curves. BMC Bioinformatics. 2011 Mar 17;12:77. doi: 10.1186/1471-2105-12-77. |
| 40011116 | Derived | Luzarraga Aznar A, Canton R, Loren G, Carvajal J, de la Calle I, Masferrer-Ferragutcasas C, Serra F, Bebia V, Bonaldo G, Angeles MA, Cabrera S, Palomar N, Vilarmau C, Marti M, Rigau M, Colas E, Gil-Moreno A. Current challenges and emerging tools in endometrial cancer diagnosis. Int J Gynecol Cancer. 2025 Apr;35(4):100056. doi: 10.1016/j.ijgc.2024.100056. Epub 2024 Dec 18. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |