Development of a Molecular Diagnostic Tool for Endometrial Cancer.

NCT06192017 | Completed

• 1 other identifier: WomEC SEGO
• Study Type: observational
• Target: 1,950
• Locations: 1 country
• Sites: 26

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 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).

Conditions

Endometrium Cancer

Keywords

Endometrial Cancer, EC

Outcome Measures

Primary Outcomes (3)

• Regulatory Requirements Study

  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

  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

  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 Outcomes (4)

• To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.

  12 months

• Evaluation of the performance of different models of WomEC to determine histological subtype.

  12 months

• Evaluation of the performance of WomEC to determine other prognostic factors of EC.

  12 months

• Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.

  12 months

Study Arms (1)

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

Interventions

WomEC DIAGNOSTIC_TEST

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.

Post-menopausal women with AUB

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: (Adult, Older Adult)
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiMARK Diagnostics, S.L.: lead
• Hospital Vall d'Hebron: collaborator

Study Sites (26)

Hospital Universitario de Torrevieja

Torrevieja, Alicante, 03186, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Dexeus - Quirón de Barcelona

Barcelona, Barcelona, 08028, Spain

Location

Hospital Universitari Campus Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario de Igualada

Igualada, Barcelona, 08700, Spain

Location

Hospital Universitari de Bellvitge - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario de la Plana

Villarreal, Castellon, 12540, Spain

Location

Hospital Clínico de Santiago

A Coruña, Galicia, 15706, Spain

Location

Hospital Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Quirónsalud Madrid

Madrid, Madrid, 28223, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Location

Hospital General Universitari de València

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario y Politécnico de La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario de Puerto Real

Cadiz, 11510, Spain

Location

Hospital General Universitari de Castelló

Castellon, 12004, Spain

Location

Hospital Universitario de León

León, 24008, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Uterine Aspirate Samples

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Antonio Gil-Moreno, MD, PhD

  Hospital Universitari Campus Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: October 18, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (26)