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The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Association between 25(OH)D level and OS

Safety Issue:

No

Principal Investigator

Alan P. Venook, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

Unspecified

Study ID:

CDR0000698059

NCT ID:

NCT01327794

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801