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

NCT02307604 | Withdrawn DMC

• 1 other identifier: EORTC-1313
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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;

Conditions

Brain Neoplasms

Keywords

Brain tumor; Biomarkers; Screening

Outcome Measures

Primary Outcomes (1)

• Number of patients with brain malignancy

  5 years

Study Arms (1)

Brain cancer

Patients with diagnosis of brain cancer at any stage

Genetic: Tumour markers testing

Interventions

Tumour markers testing GENETIC

Brain cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically confirmed brain cancer at any stage.

You may qualify if:

• 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;
• At least three months life expectancy;
• Written informed consent according to ICH/GCP and national/local regulations;

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (2)

CHRU de Lille

Lille, FR 59037, France

Location

Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

Paris, FR 75651, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE blocks of tumour tissue Blood samples

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael Weller, MD

  UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: May 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

FR (2)