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 Type
OBSERVATIONAL
Enrollment
1,950
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.
Test the ability of WomEC to discriminate between EC and non-EC patients.
Time frame: 12 months
Evaluation of the performance of different models of WomEC to determine histological subtype.
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine an histological subtype.
Time frame: 12 months
Evaluation of the performance of WomEC to determine other prognostic factors of EC.
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine other prognostic factors of EC.
Time frame: 12 months
Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.
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Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Dexeus - Quirón de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitari Campus Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
Hospital Universitario de Igualada
Igualada, Barcelona, Spain
Hospital Universitari de Bellvitge - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de la Plana
Villarreal, Castellon, Spain
...and 16 more locations
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to diagnose endometrial atypical hyperplasia.
Time frame: 12 months