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

Withdrawn

• Conditions: Brain Neoplasms

• Registration Number: NCT02307604
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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;

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Study Start: 2016-05
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with brain malignancy	5 years

Trial Locations

Locations (2)

CHRU de Lille; 🇫🇷 Lille, France

Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere; 🇫🇷 Paris, France