Study of Blood and Cheek Cell Samples From Patients With Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

San Francisco Bay Area Adult Glioma Prognosis Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009307
• Other study ID #: CDR0000437072
• Secondary ID: UCSF-H6539-04956
• Status: Completed
• Start date: October 2001

Study information

• Verified date: July 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1709
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors related to glioma survival