NCT07148154Recruiting
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
ScreenEC: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Source: ClinicalTrials.gov · Last updated 29 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
CYTOMARK, a non-invasive in vitro diagnostic (IVD) test measuring a defined panel of protein biomarkers in cervical fluid, can accurately detect endometrial cancer in both symptomatic and asymptomatic women at high risk for the disease. The aim of the study consists in validating CYTOMARK's ELISA test, creating and freezing an algorithm detect EC in post-menopausal women with abnormal uterine bleeding (AUB).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 21 Aug 2025
- Start date
- 24 Jun 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- MiMARK Diagnostics, S.L.
- Diseases
- Endometrial cancer
- NCT number
- NCT07148154
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 24 Jun 2024 to the primary completion date, 30 Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1 - Women with an active pelvic infection. 2 - 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.
Who the study is looking for
- 1 - Post-menopausal women (≥1 year without menstruation) with AUB who present with: Endometrium \> 3mm by transvaginal ultrasound, OR
- Endometrium ≤ 3mm who meet at least one of the following criteria:
- Persistent symptoms (more than one episode of metrorrhagia) Heterogenous endometrium on transvaginal ultrasonography Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.
- \- 2 - Obtaining written informed consent
Age in the registry: 40 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Campus Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.