Status:
RECRUITING
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Lead Sponsor:
MiMARK Diagnostics, S.L.
Collaborating Sponsors:
Hospital Vall d'Hebron
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
40+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT07148154
Start Date
June 24 2024
End Date
September 30 2026
Last Update
August 29 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
2
Hospital Universitari Campus Vall d'Hebron
Barcelona, Spain, 08035