Trials / Completed
CompletedNCT06192017
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,950 (actual)
- Sponsor
- MiMARK Diagnostics, S.L. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | WomEC | The study will collect pipelle biopsies from post-menopausal women presenting with AUB entering to the EC diagnostic process at the clinical consultancy or emergency room. In the study an endometrial biopsy by aspiration will be collected (i.e., pipelle biopsy) and it will be used for (1) diagnostic purposes following current procedures (i.e., pathological examination and diagnosis); (2) placed in a collection tube for WomEC test. |
Timeline
- Start date
- 2023-10-18
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
- First posted
- 2024-01-05
- Last updated
- 2025-08-28
Locations
26 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT06192017. Inclusion in this directory is not an endorsement.