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Study of Blood and Cheek Cell Samples From Patients With Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
polymorphism analysis
laboratory biomarker analysis
medical chart review
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult subependymal giant cell astrocytoma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult brain stem glioma, adult giant cell glioblastoma, adult glioblastoma, recurrent adult brain tumor, adult gliosarcoma, adult mixed glioma, adult pineal gland astrocytoma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult pineoblastoma, adult pineocytoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of glioma
  • Meets 1 of the following criteria:

    • Participant in the Survival study of San Francisco Bay Area Adult Glioma Study (SFBAAGS) Series 1 and 2
    • Treated by UCSF Neuro-Oncology Service; diagnosed between Nov. 1, 2001 and June 30, 2006 and seen between Aug. 1, 2002 and June 30, 2006
    • Participant in SFBAAGS Series 3 (not seen at UCSF Neuro-Oncology Service) diagnosed between Nov. 1, 2001 and Oct. 31, 2004

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Factors related to glioma survival

Secondary Outcome Measures

Full Information

First Posted
November 5, 2009
Last Updated
July 18, 2019
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01009307
Brief Title
Study of Blood and Cheek Cell Samples From Patients With Glioma
Official Title
San Francisco Bay Area Adult Glioma Prognosis Study Protocol
Study Type
Observational

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at blood and cheek cell samples from patients with glioma.
Detailed Description
OBJECTIVES: Primary Determine factors related to glioma survival in patients from two population-based case series collected in the San Francisco Bay Area between August 1991 and April 1994 (series 1) and May 1997 and August 1999 (series 2). Secondary Determine vital status for 879 patients in the two San Francisco Bay Area population-based series through July 2004. Determine survival as a function of established, potential, and yet unstudied prognostic indicators. Gather data to validate results from this study with information from adult glioma patients enrolled prospectively at the UCSF-Neuro-Oncology clinic and through series 3 of the San Francisco Bay Area Adult Glioma Study; incorporate results from this study and other components of the SPORE into ongoing clinical investigations at the Brain Tumor Research Center and Neuro-Oncology Service at UCSF. Using funding from the organization Accelerate Brain Cancer Cure (ABC2), genotype several thousand single nucleotide polymorphisms (SNPs) from some study participants; assess these SNPs for potential relationship to glioma survival. OUTLINE: Medical records of patients registered to the California Cancer Registry or the Northern California Cancer Center SEER are reviewed for mortality and treatment information related to the brain tumor. Blood and buccal specimens are collected from patients with newly diagnosed disease who are being seen at the UCSF Neuro-Oncology Service. The specimens are used for polymorphism and tumor marker studies and other pertinent data. Tumor specimens and treatment information related to the brain tumor are also collected from the SPORE Tissue Core. Additional tumor makers are studied, including: chromosome 1p/19q, 7q studies; DNA repair and oxidative metabolism polymorphisms; and up to 2 tumor markers and 2 constitutive genotyping studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult subependymal giant cell astrocytoma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult brain stem glioma, adult giant cell glioblastoma, adult glioblastoma, recurrent adult brain tumor, adult gliosarcoma, adult mixed glioma, adult pineal gland astrocytoma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult pineoblastoma, adult pineocytoma

7. Study Design

Enrollment
1709 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
medical chart review
Primary Outcome Measure Information:
Title
Factors related to glioma survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of glioma Meets 1 of the following criteria: Participant in the Survival study of San Francisco Bay Area Adult Glioma Study (SFBAAGS) Series 1 and 2 Treated by UCSF Neuro-Oncology Service; diagnosed between Nov. 1, 2001 and June 30, 2006 and seen between Aug. 1, 2002 and June 30, 2006 Participant in SFBAAGS Series 3 (not seen at UCSF Neuro-Oncology Service) diagnosed between Nov. 1, 2001 and Oct. 31, 2004 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Wrensch
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Study of Blood and Cheek Cell Samples From Patients With Glioma

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