CompletedNot Applicable

Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Spain1,950 participantsStarted 2023-10-18

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Endometrium \> 3mm by transvaginal ultrasound, OR
✓. Endometrium ≤ 3mm who meet at least one of the following criteria:

What they're measuring

Regulatory Requirements Study

Timeframe: 12 months

Algorithm training with Proprietary Antibodies

Timeframe: 12 months

Algorithm testing and freeze

Timeframe: 12 months

Trial details

NCT IDNCT06192017

SponsorMiMARK Diagnostics, S.L.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Endometrium Cancer trials