Development of a Molecular Diagnostic Tool for Endometrial Cancer.
NCT ID: NCT06192017
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1950 participants
OBSERVATIONAL
2023-10-18
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
NCT07148154
Identification and Characterization of Endometrial Cancer With Specific Tumor Markers in Serum and Endometrial Tissue
NCT03498924
Detection of Endometrial Cancer Through Risk Modelling
NCT06268626
Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
NCT03115593
Methylated Biomarkers Predictive of Endometrial Cancer Risk
NCT06800677
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
WomEC
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WomEC
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Endometrium \> 3mm by transvaginal ultrasound, OR
2. Endometrium ≤ 3mm who meet at least one of the following criteria:
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
* Women who have had viral infections with evidence of active and latent disease such as Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Vall d'Hebron
OTHER
MiMARK Diagnostics, S.L.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antonio Gil-Moreno, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Campus Vall d'Hebron
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Dexeus - Quirón de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitari Campus Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
Hospital Universitario de Igualada
Igualada, Barcelona, Spain
Hospital Universitari de Bellvitge - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de la Plana
Villarreal, Castellon, Spain
Hospital Clínico de Santiago
A Coruña, Galicia, Spain
Hospital Virgen de las Nieves
Granada, Granada, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Quirónsalud Madrid
Madrid, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital General Universitari de València
Valencia, Valencia, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, Valencia, Spain
Hospital Universitario de Puerto Real
Cadiz, , Spain
Hospital General Universitari de Castelló
Castellon, , Spain
Hospital Universitario de León
León, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Fawcett T. An introduction to ROC analysis. Pattern Recognit Lett. North-Holland; 2006;27:861-74.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WomEC SEGO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.