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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-151006 | |||
| CDR0000698059 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary Objective
Secondary Objective
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polymorphism analysis | Genetic |
| ||
| immunologic technique |
| Measure | Description | Time Frame |
|---|---|---|
| Association between 25(OH)D level and OS | 35 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Association between 25(OH)D level and PFS | 25 months post-randomization |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Alan Venook, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York | 12801 | United States |
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Blood samples
|
| laboratory biomarker analysis | Other |
|
| medical chart review | Other |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D007158 | Immunologic Techniques |
| ID | Term |
|---|---|
| D016172 | DNA Fingerprinting |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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