Establishment of a Brain and Spinal Tumor Tissue Bank

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686387
Recruitment Status : Unknown
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : May 29, 2008
Last Update Posted : April 12, 2011
Information provided by:
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.

Condition or disease
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 Type : Observational
Estimated 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 2008
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor [ Time Frame: 5 years ]
  2. Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol [ Time Frame: 5 years ]
  3. To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies [ Time Frame: 5 years ]
  4. To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation [ Time Frame: 5 years ]
  5. 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 [ Time Frame: 5 years ]
  6. To correlate tumor genotype and signaling abnormalities with clinical response to NAT2, EGFR, MGMT and/or other potential molecular targets inhibitors [ Time Frame: 5 years ]
  7. Analysis of laboratory findings in relationship to patient demographics and clinical course [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, Fresh tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurosurgery clinic or oncology clinic in Wan Fang Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00686387

Contact: Kuo-Sheng Hung, M.D., Ph. D. 886-2-2930-7930 ext 6942

Taipei Medical University-Wan Fang Hospital Recruiting
Taipei, Taiwan, 116
Contact: Kuo-Sheng Hung, MD, PhD    886-2-2930-7930 ext 6942   
Principal Investigator: Kuo-Sheng Hung, MD., Ph. D         
Sub-Investigator: Wen-Ta Chiu, M.D., Ph. D         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Kuo-Sheng Hung, MD, PhD Taipei Medical University-Wan Fang Hospital

Responsible Party: Kuo-Sheng Hung, MD,, Taipei Medical University-Wan Fang Hospital Identifier: NCT00686387     History of Changes
Other Study ID Numbers: 2008WFCRC-01
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Tissue Bank
Glioblastoma Multiforme
Brain and Spinal TumorGliomas

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Spinal Cord Neoplasms
Spinal Neoplasms
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases