Ahmed A. Ali
From bench to personalised medicine: clinical evaluation of brain cancer biomarkers and verification of the diagnostic system
Dr. Cristina Morelli, MTA Group, Italy
MSc Cancer & Therapeutics, Queen Mary University Of London. | BCOP, Board Certified Oncology Pharmacist. | Bachelor of Pharmacy. | MBA. | Highly interested in clinical trials as the scientific way of verifying safety and efficacy of therapeutic and diagnostic interventions.
The ultimate objective of this ESR project is to provide clinical data sustaining the preclinical data on the newly identified biomarkers. The project will be developed in two consecutive steps: 1- Clinical validation of biomarkers to be included in the GDS: a cohort of 100 patients diagnosed with glioma since maximum one year and 100 healthy control subjects aged between 40 and70 years will be recruited. Subjects personal data will be recorded at investigational site level and blood samples will be collected and homogeneously qualified by adequately trained personnel. Each blood sample will be divided in 3 parts, according to specifications provided by the referent partners involved, and shipped at controlled temperature to other Beneficiaries for subsequent analysis. All the activities related to blood samples collection/shipment will be appropriately tracked. To reduce the probability of biomarkers evaluation being affected by specific therapies administered to the patients, two separate blood samples will be collected for each subject during two visits that will be scheduled 1 month apart (T1= 0 day and T2= 30±3days). The anonymised version of patients’ data will be centrally recorded in the cloud system (HYVE). 2- Validation of GDS device suitability: in the second step of the project, a pilot study on GDS prototype developed by WP3 will be implemented, to obtain data concerning safety of the device for marketing authorisation application.