Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT01327794
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2011-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}], 'ancestors': [{'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-28', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between 25(OH)D level and OS', 'timeFrame': '35 months post-randomization'}], 'secondaryOutcomes': [{'measure': 'Association between 25(OH)D level and PFS', 'timeFrame': '25 months post-randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent pancreatic cancer', 'stage III pancreatic cancer', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This research trial is studying the relationship between vitamin D biomarkers and survival in blood samples from patients with advanced pancreatic cancer.', 'detailedDescription': "OBJECTIVES:\n\nPrimary Objective\n\n* 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).\n\nSecondary Objective\n\n* 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.\n* 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.\n\nOUTLINE: This is a multicenter study.\n\nArchived 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Eligible patients had unresectable adenocarcinoma of the pancreas\n2. Received no prior therapy for metastatic disease (prior radiation and/or chemotherapy in the adjuvant setting were allowed).\n3. Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n4. Adequate renal, liver, and bone marrow function were required.\n5. Patients signed informed consent for participation in the therapeutic trial and consented to the companion study for biomarker research (CALGB-151006).'}, 'identificationModule': {'nctId': 'NCT01327794', 'briefTitle': 'Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'The Relationship of Serum 25-Hydroxyvitamin D to Overall Survival in Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CALGB-151006'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CALGB-151006'}, {'id': 'CDR0000698059', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '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.', 'interventionNames': ['Genetic: polymorphism analysis', 'Other: immunologic technique', 'Other: laboratory biomarker analysis', 'Other: medical chart review']}], 'interventions': [{'name': 'polymorphism analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'immunologic technique', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}, {'name': 'medical chart review', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12801', 'city': 'Glens Falls', 'state': 'New York', 'country': 'United States', 'facility': 'Charles R. Wood Cancer Center at Glens Falls Hospital', 'geoPoint': {'lat': 43.30952, 'lon': -73.64401}}], 'overallOfficials': [{'name': 'Alan Venook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}