NCT01327794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

March 31, 2011

Last Update Submit

June 28, 2016

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Association between 25(OH)D level and OS

    35 months post-randomization

Secondary Outcomes (1)

  • Association between 25(OH)D level and PFS

    25 months post-randomization

Study Arms (1)

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.

Genetic: polymorphism analysisOther: immunologic techniqueOther: laboratory biomarker analysisOther: medical chart review

Interventions

polymorphism analysisGENETIC
Group 1
immunologic techniqueOTHER
Group 1
laboratory biomarker analysisOTHER
Group 1
medical chart reviewOTHER
Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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).

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Amplified Fragment Length Polymorphism AnalysisImmunologic Techniques

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Alan Venook, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 4, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

US(1)