Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer
NCT ID: NCT01327794
Last Updated: 2016-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
265 participants
OBSERVATIONAL
2011-06-30
2014-08-31
Brief Summary
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PURPOSE: This research trial is studying the relationship between vitamin D biomarkers and survival in blood samples from patients with advanced pancreatic cancer.
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Detailed Description
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Primary Objective
* 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).
Secondary Objective
* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
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.
polymorphism analysis
immunologic technique
laboratory biomarker analysis
medical chart review
Interventions
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polymorphism analysis
immunologic technique
laboratory biomarker analysis
medical chart review
Eligibility Criteria
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Inclusion Criteria
3. Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Adequate renal, liver, and bone marrow function were required.
5. Patients signed informed consent for participation in the therapeutic trial and consented to the companion study for biomarker research (CALGB-151006).
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Alan Venook, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
Countries
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Other Identifiers
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CALGB-151006
Identifier Type: -
Identifier Source: secondary_id
CDR0000698059
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-151006
Identifier Type: -
Identifier Source: org_study_id
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