Clincosm LogoSign in Get a demo

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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02307604
Collaborator
(none)
0
Enrollment
2
Locations
32
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Genetic: Tumour markers testing

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Screening Platform of EORTC for Clinical Trials Access in Brain Tumors
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Brain cancer

Patients with diagnosis of brain cancer at any stage

Genetic: Tumour markers testing

Outcome Measures

Primary Outcome Measures

  1. Number of patients with brain malignancy [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Lille Lille France FR 59037
2 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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT02307604
Other Study ID Numbers:
  • EORTC-1313
First Posted:
Dec 4, 2014
Last Update Posted:
Jun 24, 2019
Last Verified:
Jun 1, 2019
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
Brain tumor
Biomarkers
Screening
Additional relevant MeSH terms:
Brain Neoplasms

Study Results

No Results Posted as of Jun 24, 2019