Establishment of a Brain and Spinal Tumor Tissue Bank

• Conditions: Glioma; Neuroectodermal Tumors; Glioblastoma Multiforme

• Registration Number: NCT00686387
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

The purpose of this study is to establish a Brain and Spinal Tumor Tissue/Specimen repository to serve as a resource for current and future scientific studies.

Detailed Description

Glioblastoma multiforme (GBM) is the most common and lethal primary Brain and Spinal Tumor in adults. It is nearly uniformly fatal, with a median survival of approximately one year, despite modern treatment modalities. Efforts to understand why some patients live longer or shorter than the average may provide insights into the biology of these neoplasms. For years, researchers have tried to identify independent predictors that could help in treatment planning. With the recent interest in molecular biology and molecular genetics, tumor markers are now being examined as potential predictors. A marker that could predict tumor response to therapy, the likelihood of recurrence, and survival would thus be quite useful.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients must have a suspected or confirmed diagnosis of Brain and Spinal Tumor
• Age greater than 20
• Signed consent

Exclusion Criteria

• Known HIV infection
• Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.	5 years

Secondary Outcome Measures

Name	Time	Method
Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor	5 years
To correlate tumor genotype and signaling abnormalities with clinical response to NAT2, EGFR, MGMT and/or other potential molecular targets inhibitors	5 years
Analysis of laboratory findings in relationship to patient demographics and clinical course	5 years
To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies	5 years
Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol	5 years
To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation	5 years
To test the effect of small molecule inhibitors on the activation of wild-type and mutant NAT2, EGFR, MGMT and/or other potential molecular targets	5 years

Trial Locations

Locations (1)

Taipei Medical University-Wan Fang Hospital; 🇨🇳 Taipei, Taiwan