Development of a Molecular Diagnostic Tool for Endometrial Cancer.

August 21, 2025 updated by: MiMARK Diagnostics, S.L.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cadiz, Spain, 11510
        • Hospital Universitario de Puerto Real
      • Castellon, Spain, 12004
        • Hospital General Universitari de Castelló
      • León, Spain, 24008
        • Hospital Universitario de Leon
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Alicante
      • Torrevieja, Alicante, Spain, 03186
        • Hospital Universitario de Torrevieja
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Hospital Universitari Son Espases
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Barcelona, Spain, 08028
        • Hospital Dexeus - Quirón de Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Hospital Universitari Campus Vall d'Hebron
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic
      • Igualada, Barcelona, Spain, 08700
        • Hospital Universitario de Igualada
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Universitari de Bellvitge - Hospital Duran i Reynals
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Castellon
      • Villarreal, Castellon, Spain, 12540
        • Hospital Universitario de La Plana
    • Galicia
      • A Coruña, Galicia, Spain, 15706
        • Hospital Clínico de Santiago
    • Granada
      • Granada, Granada, Spain, 18014
        • Hospital Virgen de las Nieves
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
        • Hospital Universitario DE Donostia
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Hospital Materno Infantil de Gran Canaria
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe
      • Madrid, Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Madrid, Spain, 28223
        • Hospital Universitario Quirónsalud Madrid
    • Murcia
      • El Palmar, Murcia, Spain
        • Hospital Clinico Universitario Virgen de la Arrixaca
    • Valencia
      • Valencia, Valencia, Spain, 46014
        • Hospital General Universitari de València
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitario y Politecnico de la Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Post-menopausal women presenting AUB entering to the EC diagnostic process at the clinical consultancy or emergency room.

Description

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. 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-menopausal women with AUB
The patients will be divided into different study groups: "Control" and cases or "EC", the latter could be subdivided and analyzed in separate groups related to their prognosis. The "Control" patients are those patients with symptoms compatible with endometrial cancer but who are diagnosed with benign and / or healthy pathology; while "EC" patients present associated symptoms and are diagnosed with endometrial cancer.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regulatory Requirements Study
Time Frame: 12 months
Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test.
12 months
Algorithm training with Proprietary Antibodies
Time Frame: 12 months
Train the current WomEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination to rule out EC in post- menopausal women with AUB using MiMARK's proprietary antibodies.
12 months
Algorithm testing and freeze
Time Frame: 12 months
To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.
Time Frame: 12 months
Test the ability of WomEC to discriminate between EC and non-EC patients.
12 months
Evaluation of the performance of different models of WomEC to determine histological subtype.
Time Frame: 12 months
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine an histological subtype.
12 months
Evaluation of the performance of WomEC to determine other prognostic factors of EC.
Time Frame: 12 months
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine other prognostic factors of EC.
12 months
Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.
Time Frame: 12 months
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to diagnose endometrial atypical hyperplasia.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MiMARK Diagnostics, S.L.

Collaborators

Hospital Vall d'Hebron

Investigators

  • Principal Investigator: Antonio Gil-Moreno, MD, PhD, Hospital Universitari Campus Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WomEC SEGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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