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Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00897741
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 11, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date February 11, 2014
Study Start Date December 2004
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2013)
Gene expression profiles [ Time Frame: at time of biopsy ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Gene expression profiles
Change History Complete list of historical versions of study NCT00897741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer
Official Title Gene Expression Profiles in Primary and Metastatic Pancreatic Cancer
Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells with metastatic tumor cells in patients with metastatic pancreatic cancer.

Detailed Description

OBJECTIVES:

  • Compare the gene expression profiles of pancreatic cancer cells from the primary and metastatic sites in patients with metastatic pancreatic cancer.
  • Characterize the function of the differentially upregulated and downregulated genes identified by comparing the gene expression profiles of primary and metastatic cells in these patients.

OUTLINE: Fresh biopsy samples are collected for gene expression profiling and other biomarker/laboratory analyses.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cancer clinic
Condition Pancreatic Cancer
Intervention
  • Genetic: microarray analysis
  • Other: laboratory biomarker analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 9, 2009)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of pancreatic adenocarcinoma of exocrine origin
  • Metastatic disease
  • Fresh biopsy material available from primary site of disease and a metastatic focus, including liver, peritoneum, or lymph node

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for pancreatic cancer
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00897741
Other Study ID Numbers CDR0000482353
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-D-2841
WSU-HIC-091504M1E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Ann Karmanos Cancer Institute
Study Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date February 2014