Development of a Molecular Diagnostic Tool for Endometrial Cancer.

MiMARK Diagnostics

Status: Completed

Conditions: Endometrium Cancer

Treatments: Diagnostic Test: WomEC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06192017

WomEC SEGO

Details and patient eligibility

About

WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).

Enrollment: 1,950 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,950 participants in 1 patient group

Post-menopausal women with AUB

Description:

The patients will be divided into different study groups: "Control" and cases or "EC", the latter could be subdivided and analyzed in separate groups related to their prognosis. The "Control" patients are those patients with symptoms compatible with endometrial cancer but who are diagnosed with benign and / or healthy pathology; while "EC" patients present associated symptoms and are diagnosed with endometrial cancer.

Treatment:

Diagnostic Test: WomEC