Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.
PURPOSE: This research trial is studying the relationship between vitamin D biomarkers and survival in blood samples from patients with advanced pancreatic cancer.
Genetic: polymorphism analysis
Other: immunologic technique
Other: laboratory biomarker analysis
Other: medical chart review
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer|
- Association between 25(OH)D level and OS [ Time Frame: 35 months post-randomization ] [ Designated as safety issue: No ]
- Association between 25(OH)D level and PFS [ Time Frame: 25 months post-randomization ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Participants in this correlative study (CALGB 151006) were enrolled in CALGB 80303, which was a national, multi-center, double-blind phase III study that randomly assigned patients (1:1) with advanced pancreatic cancer to gemcitabine plus bevacizumab vs gemcitabine plus placebo. Blood samples were collected from consenting participants in CALGB 80303 at the time of study registration at respective institutions and shipped to the CALGB Pathology Coordinating Office for storage (Columbus, OH).Baseline serum 25-hydroxyvitamin D (25[OH]D) levels were measured and examined associations between baseline 25(OH)D levels and progression-free survival and OS using the Cox rank score test.
|Genetic: polymorphism analysis Other: immunologic technique Other: laboratory biomarker analysis Other: medical chart review|
- To measure baseline serum 25-hydroxyvitamin D (25[OH]D) levels in a cohort of patients with advanced pancreatic cancer enrolled in the Cancer and Leukemia Group B (CALGB) study 80303 and evaluate the association between vitamin D status and overall survival (OS) or progression free survival (PFS).
- To evaluate the association between common germ-line single nucleotide polymorphisms (SNPs) in the vitamin D pathway genes and 25(OH)D levels in patients with advanced pancreatic cancer.
- To evaluate the interaction between serum 25(OH)D levels and germ-line SNPs in the vitamin D pathway genes in predicting OS in advanced pancreatic cancer.
OUTLINE: This is a multicenter study.
Archived serum samples are analyzed for 25-hydroxyvitamin D levels by competitive chemiluminescence immunoassay. Results are then compared with the germ-line single nucleotide polymorphisms from the Genome-Wide Association Study (GWAS) and patients' clinical data.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327794
|United States, New York|
|Charles R. Wood Cancer Center at Glens Falls Hospital|
|Glens Falls, New York, United States, 12801|
|Principal Investigator:||Alan Venook, MD||University of California, San Francisco|