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

MiMARK Diagnostics

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Device: Cytology

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07148154

ScreenEC

Details and patient eligibility

About

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).

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

Consultancy participants

Description:

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

Treatment:

Device: Cytology