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Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00897741
First received: May 9, 2009
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Pancreatic Cancer
 Genetic: microarray analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gene Expression Profiles in Primary and Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Gene expression profiles [ Time Frame: at time of biopsy ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2004
Study Completion Date: March 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897741

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00897741     History of Changes
Other Study ID Numbers: CDR0000482353, P30CA022453, WSU-D-2841, WSU-HIC-091504M1E
Study First Received: May 9, 2009
Last Updated: April 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013