Establishment of a Brain and Spinal Tumor Tissue Bank

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00686387
• Other study ID #: 2008WFCRC-01
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2008
• Last updated: April 11, 2011
• Start date: May 2008
• Est. completion date: May 2013

Study information

• Verified date: April 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: Kuo-Sheng Hung, M.D., Ph. D.
• Phone: 886-2-2930-7930
• Email: kshung25[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.		5 years	No
Secondary	Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor		5 years	No
Secondary	Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol		5 years	No
Secondary	To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies		5 years	No
Secondary	To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation		5 years	No
Secondary	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	No
Secondary	To correlate tumor genotype and signaling abnormalities with clinical response to NAT2, EGFR, MGMT and/or other potential molecular targets inhibitors		5 years	No
Secondary	Analysis of laboratory findings in relationship to patient demographics and clinical course		5 years	No