Glioblastoma MultiformeNCT00686387
Establishment of a Brain and Spinal Tumor Tissue Bank
An observational study of Glioblastoma Multiforme and Glioma, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Glioma, Neuroectodermal Tumors
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurosurgery clinic or oncology clinic in Wan Fang Hospital
Who may be able to join
- Patients must have a suspected or confirmed diagnosis of Brain and Spinal Tumor
- Age greater than 20
- Signed consent
Who cannot join
- Known HIV infection
- Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University-Wan Fang Hospital
Taipei, 116
Kuo-Sheng Hung, MD, PhD, 886-2-2930-7930 ext. 6942, kshung25@gmail.com
Kuo-Sheng Hung, MD., Ph. D
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioblastoma Multiforme, Glioma, Neuroectodermal Tumors
- Keywords
- Tissue Bank, Glioblastoma Multiforme, NAT2, EGFR, MGMT, Brain and Spinal TumorGliomas
- Medical subject headings
- Glioblastoma, Glioma, Neuroectodermal Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.
Measured: 5 years
Secondary outcomes (7)
Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor
Measured: 5 years
Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol
Measured: 5 years
To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies
Measured: 5 years
To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation
Measured: 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
Measured: 5 years
To correlate tumor genotype and signaling abnormalities with clinical response to NAT2, EGFR, MGMT and/or other potential molecular targets inhibitors
Measured: 5 years
Analysis of laboratory findings in relationship to patient demographics and clinical course
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kuo-Sheng Hung, MD, PhD, Principal investigator, Taipei Medical University-Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686387
- Sponsor's protocol ID
- 2008WFCRC-01
- Status last verified
- Apr 2011
- First submitted
- 26 May 2008
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Brain and Spinal Tumor Tissue Bank and Clinical Data Repository for Identifying Molecular Markers of Clinical Outcome
- ClinicalTrials.gov ID
- NCT00686387
- Acronym / sponsor ID
- 2008WFCRC-01
- Conditions
- Glioblastoma Multiforme, Glioma, Neuroectodermal Tumors
- Keywords
- Tissue Bank, Glioblastoma Multiforme, NAT2, EGFR, MGMT, Brain and Spinal TumorGliomas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 29 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgery clinic or oncology clinic in Wan Fang Hospital
Key inclusion criteria (3 listed)
- Patients must have a suspected or confirmed diagnosis of Brain and Spinal Tumor
- Age greater than 20
- Signed consent
Key exclusion criteria (2 listed)
- Known HIV infection
- Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.
Time frame: 5 years
7 secondary outcomes
Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor
Time frame: 5 years
Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol
Time frame: 5 years
To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies
Time frame: 5 years
To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation
Time frame: 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
Time frame: 5 years
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
Analysis of laboratory findings in relationship to patient demographics and clinical course
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuo-Sheng Hung, MD, PhD principal investigator
Taipei Medical University-Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme and Glioma, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuo-Sheng Hung, M.D., Ph. D. (886-2-2930-7930 ext. 6942, kshung25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011.