NCT07148154

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: MiMARK Diagnostics, S.L. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DEVICE	Cytology	Two cervical samples are collected using a cervical brush or swab, following the standard procedure for cervical cytology. Cells are taken from the cervix using a brush/spatula during a gynecological exam. (1) The first sample is kept in the clinical center's pathology department for examination. (2) The second sample is sent to MiMARK's facilities for the investigational project, where it will be processed and stored for future cohort selection and analysis.

Timeline

• Start date: 2024-06-24
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

2 sites across 1 country: Spain