Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations

Recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT07148154
• Lead Sponsor: MiMARK Diagnostics, S.L.

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Status Verified: 2025-08
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regulatory Requirements Study	12 months	Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed ScreeEC's ELISA test.
Algorithm training with Proprietary Antibodies	12 months	Train the current ScreenEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination detect EC in post- menopausal women with AUB using MiMARK's proprietary antibodies.
Algorithm testing and freeze	12 months	To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.

Trial Locations

Locations (2)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitari Campus Vall d'Hebron; 🇪🇸 Barcelona, Spain