Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01327794|
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : June 29, 2016
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.
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer||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.
|Study Type :||Observational|
|Actual Enrollment :||265 participants|
|Official Title:||The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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|
- Association between 25(OH)D level and OS [ Time Frame: 35 months post-randomization ]
- Association between 25(OH)D level and PFS [ Time Frame: 25 months post-randomization ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|