RecruitingNCT07148154

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

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

Sponsor

MiMARK Diagnostics, S.L.

Enrollment

3,000 participants

Start Date

Jun 24, 2024

Study Type

OBSERVATIONAL

Conditions

Endometrial Cancer

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).

Eligibility

Sex: FEMALEMin Age: 40 Years

Inclusion Criteria4

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 Criteria1

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.

Interventions

DEVICECytology

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.