From prospective biobanking to precision medicine: BIO-RAIDs – an EU study protocol in cervical cancer

[摘要] BackgroundCervical cancer (CC) is -second to breast cancer- a dominant cause of gynecological cancer-related deaths worldwide. CC tumor biopsies and blood samples are of easy access and vital for the development of future precision medicine strategies.DesignBIO-RAIDs is a prospective multicenter European study, presently recruiting patients in 6 EU countries. Tumor and liquid biopsies from patients with previously non-treated cervical cancer (stages IB2-IV) are collected at defined time points. Patients receive standard primary treatment according to the stage of their disease. 700 patients are planned to be enrolled. The main objectives are the discovery of -dominant molecular alterations, -signalling pathway activation, and -tumor micro-environment patterns that may predict response or resistance to treatment. An exhaustive molecular analysis is performed using 1° Next generation sequencing, 2° Reverse phase protein arrays and 3° Immuno-histochemistry.DiscussionThe clinical study BIO-RAIDs is activated in all planned countries, 170 patients have been recruited till now. This study will make an important contribution towards precision medicine treatments in cervical cancer. The results will support the development of clinical practice guidelines for cervical cancer patients to improve their prognosis and their quality of life.Trial registrationClinicaltrials.gov: NCT02428842, registered 10 February 2015.

[发布日期] 2015-11-04

[关键词] Prospective European biobanking study;Precision medicine;Molecular profiling;Cervical cancer;Next generation sequencing;Reverse phase protein array;Tumor micro environment;Targeted therapy;Patient stratification;International trial;Clinical trial operations;Quality control of pelvic radiotherapy;Biobanking;HPV typing