CYTOMARK, a non-invasive in vitro diagnostic (IVD) test measuring a defined panel of protein biomarkers in cervical fluid, can accurately detect endometrial cancer in both symptomatic and asymptomatic women at high risk for the disease. The aim of the study consists in validating CYTOMARK's ELISA test, creating and freezing an algorithm detect EC in post-menopausal women with abnormal uterine bleeding (AUB).
Study Type
OBSERVATIONAL
Enrollment
3,000
Two cervical samples are collected using a cervical brush or swab, following the standard procedure for cervical cytology. Cells are taken from the cervix using a brush/spatula during a gynecological exam. (1) The first sample is kept in the clinical center's pathology department for examination. (2) The second sample is sent to MiMARK's facilities for the investigational project, where it will be processed and stored for future cohort selection and analysis.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital Universitari Campus Vall d'Hebron
Barcelona, Spain
RECRUITINGRegulatory Requirements Study
Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed ScreeEC's ELISA test.
Time frame: 12 months
Algorithm training with Proprietary Antibodies
Train the current ScreenEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination detect 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.