Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Last updated: August 21, 2025
Sponsor: MiMARK Diagnostics, S.L.
Overall Status: Completed

Phase

N/A

Condition

Endometrial Cancer

Treatment

WomEC

Clinical Study ID

NCT06192017
WomEC SEGO
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

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. Heterogenousendometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use oftamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.

  • Obtaining written informed consent

Exclusion

Exclusion Criteria:

  • Women with an active pelvic infection.

  • Women who have had viral infections with evidence of active and latent disease suchas Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C inthe past but who have been successfully treated and in whom viral replication hasnot been observed in the last year will be included.

Study Design

Total Participants: 1950
Treatment Group(s): 1
Primary Treatment: WomEC
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Hospital Universitario de Torrevieja

    Torrevieja, Alicante 03186
    Spain

    Site Not Available

  • Hospital Universitario de Torrevieja

    Torrevieja 2510253, Alicante 03186
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma De Mallorca, Balearic Islands 07120
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma de Mallorca 2512989, Balearic Islands 2521383 07120
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona 3129028, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Clinic

    Barcelona 3128760, Barcelona 08036
    Spain

    Site Not Available

  • Hospital Dexeus - Quirón de Barcelona

    Barcelona 3128760, Barcelona 08028
    Spain

    Site Not Available

  • Hospital Universitari Campus Vall d'Hebron

    Barcelona 3128760, Barcelona 08035
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge - Hospital Duran i Reynals

    Hospitalet de Llobregat, Barcelona 08908
    Spain

    Site Not Available

  • Hospital Universitario de Igualada

    Igualada 3120431, Barcelona 08700
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge - Hospital Duran i Reynals

    L'Hospitalet de Llobregat 3120619, Barcelona 08908
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Universitario de la Plana

    Villarreal 2509493, Castellon 12540
    Spain

    Site Not Available

  • Hospital Clínico de Santiago

    A Coruña 3119841, Galicia 3336902 15706
    Spain

    Site Not Available

  • Hospital Virgen de las Nieves

    Granada 2517117, Granada 18014
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia, Guipuzcoa 20014
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia / San Sebastian 3110044, Guipuzcoa 20014
    Spain

    Site Not Available

  • Hospital Materno Infantil de Gran Canaria

    Las Palmas De Gran Canaria, Las Palmas 35016
    Spain

    Site Not Available

  • Hospital Materno Infantil de Gran Canaria

    Las Palmas de Gran Canaria 2515270, Las Palmas 35016
    Spain

    Site Not Available

  • Hospital Universitario de Getafe

    Getafe, Madrid 28905
    Spain

    Site Not Available

  • Hospital Universitario de Getafe

    Getafe 3121437, Madrid 3117732 28905
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid 3117735, Madrid 3117732 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, Madrid 3117732 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, Madrid 3117732 28046
    Spain

    Site Not Available

  • Hospital Universitario Quirónsalud Madrid

    Madrid 3117735, Madrid 3117732 28223
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar 2518294, Murcia 2513413
    Spain

    Site Not Available

  • Hospital General Universitari de València

    Valencia 2509954, Valencia 2593113 46014
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico de La Fe

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Site Not Available

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Campus Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario de Puerto Real

    Cadiz, 11510
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Cadiz 2520600, 11510
    Spain

    Site Not Available

  • Hospital General Universitari de Castelló

    Castellon 2519752, 12004
    Spain

    Site Not Available

  • Hospital General Universitari de Castelló

    Castelló de la Plana, 12004
    Spain

    Site Not Available

  • Hospital Universitario de León

    León, 24008
    Spain

    Site Not Available

  • Hospital Universitario de León

    León 3118532, 24008
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Quirónsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • Hospital General Universitari de València

    Valencia, 46014
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico de La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Miguel Servet

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

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