Clinical trial NCT00686387: Establishment of a Brain and Spinal Tumor Tissue Bank
Official title: Establishment of a Brain and Spinal Tumor Tissue Bank and Clinical Data Repository for Identifying Molecular Markers of Clinical Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma Multiforme
Glioma
Neuroectodermal Tumors
Keywords: Tissue Bank
Glioblastoma Multiforme
NAT2
EGFR
MGMT
Brain and Spinal TumorGliomas
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurosurgery clinic or oncology clinic in Wan Fang 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.

Eligibility criteria: 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

Primary outcomes:
measure: Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.
timeFrame: 5 years
Secondary outcomes:
measure: Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor
timeFrame: 5 years
measure: Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol
timeFrame: 5 years
measure: To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies
timeFrame: 5 years
measure: To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: To correlate tumor genotype and signaling abnormalities with clinical response to NAT2, EGFR, MGMT and/or other potential molecular targets inhibitors
timeFrame: 5 years
measure: Analysis of laboratory findings in relationship to patient demographics and clinical course
timeFrame: 5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Kuo-Sheng Hung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: