Establishment of a Brain and Spinal Tumor Tissue Bank
Recruitment status was Recruiting
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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 |
- 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 ]
- 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) |
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 |
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
Contacts and Locations| Contact: Kuo-Sheng Hung, M.D., Ph. D. | 886-2-2930-7930 ext 6942 | kshung25@gmail.com |
| 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 | |
| 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:
|
Glioblastoma Glioma Spinal Cord Neoplasms Spinal Neoplasms Neuroectodermal Tumors Astrocytoma Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms 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 |
ClinicalTrials.gov processed this record on June 17, 2013