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

This study is currently recruiting participants.
Verified May 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01327794
First received: March 31, 2011
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Pancreatic Cancer
 Genetic: polymorphism analysis
Other: immunologic technique
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Association between 25(OH)D level and OS [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association between SNPs and vitamin D pathway genes [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: June 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with advanced pancreatic cancer
  • Available serum samples stored at the CALGB Pathology Coordinating Office (PCO) at Ohio State University
  • Enrolled and randomized on CALGB-80303 trial

PATIENT CHARACTERISTICS:

  • Patients who have previously provided informed consent allowing correlative studies on samples

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327794

Locations
United States, New York
Charles R. Wood Cancer Center at Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen     518-926-6700        
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alan P. Venook, MD University of California, San Francisco
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01327794     History of Changes
Other Study ID Numbers: CDR0000698059, CALGB-151006
Study First Received: March 31, 2011
Last Updated: May 3, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013