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

Brain Neoplasms Clinical Trial

— SPECTAbrain  

Official title:

Screening Platform of EORTC for Clinical Trials Access in Brain Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02307604
• Other study ID #: EORTC-1313
• Status: Withdrawn
• Start date: May 2016
• Est. completion date: January 2019

Study information

• Verified date: June 2019
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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;

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Genetic:
• Tumour markers testing

Locations

Country	Name	City	State
France	CHRU de Lille	Lille
France	Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with brain malignancy		5 years