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

NCT07148154 | Recruiting

• 1 other identifier: ScreenEC
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

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

Keywords

Endometrial Cancer; IVD; In-vitro Diagnostics; Endometrial adenocarcinoma; diagnostics

Outcome Measures

Primary Outcomes (3)

• Regulatory Requirements Study

  Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed ScreeEC's ELISA test.

  12 months

• Algorithm training with Proprietary Antibodies

  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.

  12 months

• Algorithm testing and freeze

  To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.

  12 months

Study Arms (1)

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

Device: Cytology

Interventions

Cytology 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.

Consultancy participants

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiMARK Diagnostics, S.L.: lead
• Hospital Vall d'Hebron: collaborator

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitari Campus Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cytology specimen, cervical sample

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cytological Techniques

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Antonio Gil-Moreno, MD, PhD

  Hospital Universitari Campus Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Gil-Moreno, MD, PhD

CONTACT

934893066; antonio.gil@vallhebron.cat

Eva Colás, PhD

CONTACT

934893066; eva.colas@mimark.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: June 24, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

ES (2)