Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Recruiting

• Conditions: Endometrium Cancer
• Interventions: Diagnostic Test: WomEC

• Registration Number: NCT06192017
• Lead Sponsor: MiMARK Diagnostics, S.L.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-18
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Status Verified: 2024-01
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-menopausal women with AUB	WomEC	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.

Primary Outcome Measures

Name	Time	Method
Regulatory Requirements Study	12 months	Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test.
Algorithm testing and freeze	12 months	To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.
Algorithm training with Proprietary Antibodies	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.

Secondary Outcome Measures

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

Trial Locations

Locations (19)

Hospital Universitario de Donostia; 🇪🇸 Donostia, Guipuzcoa, Spain

Hospital Universitario de León; 🇪🇸 León, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Materno Infantil de Gran Canaria; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital General Universitari de València; 🇪🇸 Valencia, Spain

Hospital Universitario y Politécnico de La Fe; 🇪🇸 Valencia, Spain

Hospital Universitari Campus Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital General Universitari de Castelló; 🇪🇸 Castelló de la Plana, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario de Torrevieja; 🇪🇸 Torrevieja, Alicante, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario Quirónsalud Madrid; 🇪🇸 Madrid, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma De Mallorca, Balearic Islands, Spain

Hospital Universitari de Bellvitge - Hospital Duran i Reynals; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Puerto Real; 🇪🇸 Cadiz, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain