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

June 20, 2019 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Screening Platform of EORTC for Clinical Trials Access in Brain Tumors

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;

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, FR 59037
        • CHRU de Lille
      • Paris, France, FR 75651
        • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pathologically confirmed brain cancer at any stage.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brain cancer
Patients with diagnosis of brain cancer at any stage
Genetic: Tumour markers testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with brain malignancy
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Michael Weller, MD, UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Neoplasms

Clinical Trials on Tumour markers testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe