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Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Sponsor: MiMARK Diagnostics, S.L.
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).
Official title: ScreenEC: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Key Details
Gender
FEMALE
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2024-06-24
Completion Date
2026-09-30
Last Updated
2025-08-29
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (2)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Campus Vall d'Hebron
Barcelona, Spain