Establishment of a Brain and Spinal Tumor Tissue Bank

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

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.

Study Overview

• Status: Unknown
• Conditions: Glioma; Neuroectodermal Tumors; Glioblastoma Multiforme

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Kuo-Sheng Hung, M.D., Ph. D.; Phone Number: 6942 886-2-2930-7930; Email: kshung25@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Recruiting
    • Taipei Medical University-Wan Fang Hospital
    • Contact: Kuo-Sheng Hung, MD, PhD; Phone Number: 6942 886-2-2930-7930; Email: kshung25@gmail.com
    • Principal Investigator: Kuo-Sheng Hung, MD., Ph. D
    • Sub-Investigator: Wen-Ta Chiu, M.D., Ph. D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neurosurgery clinic or oncology clinic in Wan Fang Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Kuo-Sheng Hung, MD, PhD, Taipei Medical University-Wan Fang Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: May 26, 2008
• First Submitted That Met QC Criteria: May 28, 2008
• First Posted (Estimate): May 29, 2008

Study Record Updates

• Last Update Posted (Estimate): April 12, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Glioblastoma Multiforme; EGFR; MGMT; Tissue Bank; NAT2; Brain and Spinal TumorGliomas
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive
• Other Study ID Numbers: 2008WFCRC-01