Clinical trial · Observational
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
NCT06192017CI-TRIAL-00094254completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrium Cancer | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WomEC | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Post-menopausal women with AUB
- description
- 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.
- interventionNames
- Diagnostic Test: WomEC
Primary outcomes (3)
- measure
- Regulatory Requirements Study
- timeFrame
- 12 months
- description
- Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test.
- measure
- Algorithm training with Proprietary Antibodies
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Post-menopausal women (≥1 year without menstruation) with AUB who present with: 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 with an active pelvic infection. * 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.
References
Publications (17)
- BACKGROUNDBray 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. PMID 30207593
- BACKGROUNDSiegel 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. PMID 35020204
- BACKGROUNDDueholm 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. PMID 29944932
- BACKGROUNDClarke 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. PMID 30083701
- BACKGROUNDvan 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. PMID 26748390
- BACKGROUNDBradley 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. PMID 12151831
- BACKGROUNDHelpman 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.