A new diagnostic tool for detecting endometrial cancer.
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
This study is testing a new diagnostic tool that looks for endometrial cancer in post-menopausal women with abnormal bleeding by checking certain proteins in their biopsy samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | MiMARK Diagnostics, S.L. Industry-sponsored |
| Locations | 19 sites (Torrevieja, Alicante and 18 other locations) |
| Trial ID | NCT06192017 on ClinicalTrials.gov |
What this trial studies
This study focuses on validating WomEC, an in vitro diagnostic test designed to detect endometrial cancer by analyzing the expression levels of five specific proteins in biopsy samples from post-menopausal women with abnormal uterine bleeding. The goal is to create and freeze an algorithm that can effectively rule out endometrial cancer in this patient population. Participants will include women who meet specific criteria based on ultrasound findings and risk factors. The study is observational and aims to improve diagnostic accuracy for endometrial cancer.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women experiencing abnormal uterine bleeding with specific ultrasound findings or risk factors.
Not a fit: Patients with active pelvic infections or certain viral infections like Hepatitis B, Hepatitis C, or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this diagnostic tool could lead to earlier and more accurate detection of endometrial cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using protein biomarkers for cancer detection, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Torrevieja, Alicante and 18 other locations
- Hospital Universitario de Torrevieja — Torrevieja, Alicante, Spain (Recruiting)
- Hospital Universitari Son Espases — Palma De Mallorca, Balearic Islands, Spain (Recruiting)
- Hospital Universitari de Bellvitge - Hospital Duran i Reynals — Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitario de Donostia — Donostia, Guipuzcoa, Spain (Recruiting)
- Hospital Materno Infantil de Gran Canaria — Las Palmas De Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital Universitario de Getafe — Getafe, Madrid, Spain (Recruiting)
- Hospital Universitari Campus Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Clinic — Barcelona, Spain (Recruiting)
- Hospital Universitario de Puerto Real — Cadiz, Spain (Recruiting)
- Hospital General Universitari de Castelló — Castelló de la Plana, Spain (Recruiting)
- Hospital Universitario de León — León, Spain (Recruiting)
- Hospital Clinico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Hospital Universitario Quirónsalud Madrid — Madrid, Spain (Recruiting)
- Hospital General Universitari de València — Valencia, Spain (Recruiting)
- Hospital Universitario y Politécnico de La Fe — Valencia, Spain (Recruiting)
- Hospital Miguel Servet — Zaragoza, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Gil-Moreno, MD, PhD — Hospital Universitari Campus Vall d'Hebron
- Study coordinator: Antonio Gil-Moreno, MD, PhD
- Email: antonio.gil@vallhebron.cat
- Phone: 934893066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.