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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307604
Recruitment Status : Withdrawn (This study has been merged with 1553 SPECTA, in which brain patients are enrolled)
First Posted : December 4, 2014
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
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;

Condition or disease Intervention/treatment
Brain Neoplasms Genetic: Tumour markers testing

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Screening Platform of EORTC for Clinical Trials Access in Brain Tumors
Study Start Date : May 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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



Primary Outcome Measures :
  1. Number of patients with brain malignancy [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
FFPE blocks of tumour tissue Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pathologically confirmed brain cancer at any stage.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307604


Locations
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France
CHRU de Lille
Lille, France, FR 59037
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
Paris, France, FR 75651
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Michael Weller, MD UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland

Additional Information:

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02307604     History of Changes
Other Study ID Numbers: EORTC-1313
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Brain tumor
Biomarkers
Screening
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases