Status:
COMPLETED
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
Lead Sponsor:
MiMARK Diagnostics, S.L.
Collaborating Sponsors:
Hospital Vall d'Hebron
Conditions:
Endometrium Cancer
Eligibility:
FEMALE
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Post-menopausal women (≥1 year without menstruation) with AUB who present with:
- Endometrium \> 3mm by transvaginal ultrasound, OR
- 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
- 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.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
1950 Patients enrolled
Trial Details
Trial ID
NCT06192017
Start Date
October 18 2023
End Date
July 31 2025
Last Update
August 28 2025
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain, 03186
2
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
3
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
4
Hospital Dexeus - Quirón de Barcelona
Barcelona, Barcelona, Spain, 08028