Establishment of a Brain and Spinal Tumor Tissue Bank

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00686387

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme Glioma Neuroectodermal Tumors

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 Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Establishment of a Brain and Spinal Tumor Tissue Bank and Clinical Data Repository for Identifying Molecular Markers of Clinical Outcome

Study Start Date :

May 1, 2008

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

May 1, 2013

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor [5 years]
Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol [5 years]
To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies [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]
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]