Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Launched by MIMARK DIAGNOSTICS, S.L. · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new diagnostic test called WomEC, which aims to help detect endometrial cancer in post-menopausal women who experience abnormal uterine bleeding. The test works by analyzing a small sample of tissue taken from the uterus to measure the levels of five specific proteins. The goal is to validate this test so that doctors can use it to rule out endometrial cancer in women who might be at risk, especially those with certain symptoms or medical conditions.

To be eligible for the trial, participants need to be post-menopausal women who have not had a period for at least a year and are experiencing abnormal bleeding. They should also have certain ultrasound findings related to their endometrium, which is the lining of the uterus. Women with active pelvic infections or certain viral infections will not be included in the study. Participants will be asked to provide their written consent and can expect to contribute to research that could lead to better diagnostic tools for endometrial cancer in the future. This trial is currently recruiting participants, and more information can be obtained from the study coordinators.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * Post-menopausal women (≥1 year without menstruation) with AUB who present with:
• • 1. Endometrium \> 3mm by transvaginal ultrasound, OR
• 2. Endometrium ≤ 3mm who meet at least one of the following criteria:
• • i. Persistent symptoms (more than one episode of metrorrhagia) ii. Heterogenous endometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.
• • Obtaining written informed consent
• Exclusion Criteria:
• • Women with an active pelvic infection.
• • 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.