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Completed

NCT Number: NCT06192017

Development of a Molecular Diagnostic Tool for Endometrial Cancer.

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).

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Key information

Conditions

Endometrium Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario de Torrevieja, Torrevieja, Alicante, Spain

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

MiMARK Diagnostics, S.L.

Industry

Collaborators

  • Hospital Vall d'Hebron

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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