NCT00686387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

5 years

First QC Date

May 26, 2008

Last Update Submit

April 11, 2011

Conditions

Keywords

Tissue BankGlioblastoma MultiformeNAT2EGFRMGMTBrain and Spinal TumorGliomas

Outcome Measures

Primary Outcomes (1)

  • Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.

    5 years

Secondary Outcomes (7)

  • Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor

    5 years

  • Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol

    5 years

  • To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies

    5 years

  • To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation

    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

    5 years

  • +2 more secondary outcomes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurosurgery clinic or oncology clinic in Wan Fang Hospital

You may qualify if:

  • Patients must have a suspected or confirmed diagnosis of Brain and Spinal Tumor
  • Age greater than 20
  • Signed consent

You may not qualify if:

  • Known HIV infection
  • Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University-Wan Fang Hospital

Taipei, 116, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Fresh tissue

MeSH Terms

Conditions

GlioblastomaGliomaNeuroectodermal Tumors

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Kuo-Sheng Hung, MD, PhD

    Taipei Medical University-Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo-Sheng Hung, M.D., Ph. D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2008

First Posted

May 29, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 12, 2011

Record last verified: 2011-04

Locations