Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Last updated: January 25, 2024
Sponsor: MiMARK Diagnostics, S.L.
Overall Status: Active - Recruiting

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 such asHepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in thepast but who have been successfully treated and in whom viral replication has not beenobserved in the last year will be included.

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: WomEC
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
October 17, 2024

Connect with a study center

  • Hospital Universitario de Torrevieja

    Torrevieja, Alicante 03186
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma De Mallorca, Balearic Islands 07120
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge - Hospital Duran i Reynals

    Hospitalet de Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    Donostia, Guipuzcoa 20014
    Spain

    Active - Recruiting

  • Hospital Materno Infantil de Gran Canaria

    Las Palmas De Gran Canaria, Las Palmas 35016
    Spain

    Active - Recruiting

  • Hospital Universitario de Getafe

    Getafe, Madrid 28905
    Spain

    Active - Recruiting

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Campus Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario de Puerto Real

    Cadiz, 11510
    Spain

    Active - Recruiting

  • Hospital General Universitari de Castelló

    Castelló de la Plana, 12004
    Spain

    Active - Recruiting

  • Hospital Universitario de León

    León, 24008
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • 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

    Active - Recruiting

  • Hospital Miguel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

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