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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-01-31

Brief Summary

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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;

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Detailed Description

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Conditions

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Brain Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain cancer

Patients with diagnosis of brain cancer at any stage

Tumour markers testing

Intervention Type GENETIC

Interventions

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Tumour markers testing

Intervention Type GENETIC

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No