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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01327794

Enrollment

265

Registered

2011-04-04

Start date

2011-06-30

Completion date

2014-08-31

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer, stage III pancreatic cancer, stage IV 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.

Interventions

GENETICpolymorphism analysis

OTHERimmunologic technique

OTHERlaboratory biomarker analysis

OTHERmedical chart review

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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).

Design outcomes

Primary

Measure	Time frame
Association between 25(OH)D level and OS	35 months post-randomization

Secondary

Measure	Time frame
Association between 25(OH)D level and PFS	25 months post-randomization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026