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Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01327794
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : June 29, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date March 31, 2011
First Posted Date April 4, 2011
Last Update Posted Date June 29, 2016
Study Start Date June 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2016)
Association between 25(OH)D level and OS [ Time Frame: 35 months post-randomization ]
Original Primary Outcome Measures
 (submitted: March 31, 2011)
Association between 25(OH)D level and OS
Change History Complete list of historical versions of study NCT01327794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 27, 2016)
Association between 25(OH)D level and PFS [ Time Frame: 25 months post-randomization ]
Original Secondary Outcome Measures
 (submitted: March 31, 2011)
  • Association between SNPs and vitamin D pathway genes
  • Progression-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer
Official Title The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer
Brief Summary

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.

Detailed Description

OBJECTIVES:

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Patients had unresectable adenocarcinoma of the pancreas and had received no prior therapy for metastatic disease (prior radiation and/or chemotherapy in the adjuvant setting were allowed).
Condition Pancreatic Cancer
Intervention
  • Genetic: polymorphism analysis
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
  • Other: medical chart review
Study Groups/Cohorts 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.
Interventions:
  • Genetic: polymorphism analysis
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
  • Other: medical chart review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2016)
265
Original Estimated Enrollment
 (submitted: March 31, 2011)
220
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria
  1. Eligible patients had unresectable adenocarcinoma of the pancreas
  2. Received no prior therapy for metastatic disease (prior radiation and/or chemotherapy in the adjuvant setting were allowed).
  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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01327794
Other Study ID Numbers CALGB-151006
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-151006
CDR0000698059 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Alan Venook, MD University of California, San Francisco
PRS Account Alliance for Clinical Trials in Oncology
Verification Date June 2016