SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access

Screening Platform of EORTC for Clinical Trials Access in Brain Tumors

The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:

• Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
• Identify or validate new molecularly defined subgroups of tumors;
• Investigate the prevalence of novel biomarkers to plan future clinical trials;
• Enable exploratory/future research;
• Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;

Inclusion Criteria:

• Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;
• Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
• At least three months life expectancy;
• Written informed consent according to ICH/GCP and national/local regulations;
• Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.