Actively Recruiting
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Led by MiMARK Diagnostics, S.L. · Updated on 2025-08-29
3000
Participants Needed
2
Research Sites
118 weeks
Total Duration
On this page
Sponsors
M
MiMARK Diagnostics, S.L.
Lead Sponsor
H
Hospital Vall d'Hebron
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menopausal women (at least 1 year without menstruation) with abnormal uterine bleeding who have either: an endometrium thicker than 3mm by transvaginal ultrasound, OR an endometrium 3mm or less plus at least one of the following: persistent bleeding episodes, heterogeneous endometrium on ultrasound, or risk factors such as BMI of 30 or higher, use of tamoxifen, hormone replacement therapy, Lynch syndrome, or BRCA mutation
- Ability to provide written informed consent
You will not qualify if you...
- Women with an active pelvic infection
- Women with active or latent viral infections including Hepatitis B, Hepatitis C, or HIV, except those previously treated for Hepatitis C with no viral replication in the last year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
2
Hospital Universitari Campus Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
A
Antonio Gil-Moreno, MD, PhD
CONTACT
E
Eva Colás, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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