SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access
Conditions
Brain Neoplasms
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
Brain tumor, Biomarkers, Screening
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Tumour markers testing
Type: Genetic
Overall Status
Not yet recruiting
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;
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Start Date
March 2015
Completion Date
January 2019
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Source
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page