Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Development of a Molecular Diagnostic Tool for Endometrial Cancer.

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).

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.