Brain Neoplasms
Conditions
Keywords
Brain tumor, Biomarkers, Screening
Brief summary
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;
Interventions
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with brain malignancy | 5 years |
Countries
France