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

Overview

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;

Full Title of Study: “Screening Platform of EORTC for Clinical Trials Access in Brain Tumors”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2019

Interventions

  • Genetic: Tumour markers testing

Arms, Groups and Cohorts

  • Brain cancer
    • Patients with diagnosis of brain cancer at any stage

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with brain malignancy
    • Time Frame: 5 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Organisation for Research and Treatment of Cancer – EORTC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Weller, MD, Study Chair, UniversitaetsSpital Zurich – Department of Neurology, Zurich, Switzerland

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