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

NCT07148154 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-08-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Vall d'Hebron

    collaborator OTHER

  • MiMARK Diagnostics, S.L.

    lead INDUSTRY

Principal Investigators

  • Antonio Gil-Moreno, MD, PhD · Hospital Universitari Campus Vall d'Hebron

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148154 on ClinicalTrials.gov