Establishment of a Brain and Spinal Tumor Tissue Bank

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00686387
First received: May 26, 2008
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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
Glioblastoma Multiforme
Glioma
Neuroectodermal Tumors

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Analysis of laboratory findings in relationship to patient demographics and clinical course [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, Fresh tissue


Estimated Enrollment: 70
Study Start Date: May 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neurosurgery clinic or oncology clinic in Wan Fang Hospital

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686387

Contacts
Contact: Kuo-Sheng Hung, M.D., Ph. D. 886-2-2930-7930 ext 6942 kshung25@gmail.com

Locations
Taiwan
Taipei Medical University-Wan Fang Hospital Recruiting
Taipei, Taiwan, 116
Contact: Kuo-Sheng Hung, MD, PhD    886-2-2930-7930 ext 6942    kshung25@gmail.com   
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
Investigators
Principal Investigator: Kuo-Sheng Hung, MD, PhD Taipei Medical University-Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Kuo-Sheng Hung, MD,, Taipei Medical University-Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00686387     History of Changes
Other Study ID Numbers: 2008WFCRC-01
Study First Received: May 26, 2008
Last Updated: April 11, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Tissue Bank
Glioblastoma Multiforme
NAT2
EGFR
MGMT
Brain and Spinal TumorGliomas

Additional relevant MeSH terms:
Neuroectodermal Tumors
Glioblastoma
Spinal Cord Neoplasms
Spinal Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
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

ClinicalTrials.gov processed this record on September 16, 2014