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

NCT ID: NCT07148154

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2026-09-30

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).

Conditions

Endometrial Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Consultancy participants

Eligible participants are postmenopausal women presenting with abnormal uterine bleeding (AUB) in a clinical consultation or primary care setting, for whom a cytology procedure is performed. Cervical samples must be obtainable directly during the consultation at clinical centers with prior Ethics Committee approval. Only participants who meet all inclusion criteria and none of the exclusion criteria will be enrolled

Cytology

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Vall d'Hebron

OTHER

Sponsor Role: collaborator

MiMARK Diagnostics, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Gil-Moreno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Campus Vall d'Hebron

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitari Campus Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Antonio Gil-Moreno, MD, PhD

Role: CONTACT

antonio.gil@vallhebron.cat

934893066 ext. 34

Eva Colás, PhD

Role: CONTACT

eva.colas@mimark.es

934893066 ext. 34

Facility Contacts

Laura Costas, PhD

Role: primary

lcostas@iconcologia.net

670843028 ext. 34

Marta López, PhD

Role: backup

Antonio Gil-Moreno, MD, PhD

Role: primary

antonio.gil@vallhebron.cat

934893066 ext. 34

Other Identifiers

ScreenEC

Identifier Type: -

Identifier Source: org_study_id