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Clinical Trials/NCT00633334
NCT00633334
Completed
Not Applicable

Investigation of the Immune Response to Gastrointestinal Tumors and Development of Novel Biomarkers for the Presence of Gastrointestinal Cancer

University of Pittsburgh1 site in 1 country2,499 target enrollmentSeptember 2003
ConditionsGI Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
GI Cancer
Sponsor
University of Pittsburgh
Enrollment
2499
Locations
1
Primary Endpoint
The first goal of this proposal is to collect cells from the peripheral blood, tumor draining lymph nodes and tumor infiltrating lymphocytes in patients with early or late stage gastrointestinal cancers.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Therapies involving the immune system have already shown great promise in early clinical trials for the treatment of renal cell carcinoma and melanoma. One of the great challenges now facing this field is to extend these findings to other cancers. Little is currently understood about the nature of the immune response to more common gastrointestinal cancers. The first goal of this proposal is to collect blood and tissue samples from patients with early or late stage gastrointestinal cancers. These samples will be evaluated to better understand the immune response to these two cancers. The second goal of this proposal is to evaluate the specimens of these patients for changes and genetic markers that correlate with the presence of cancer. The information gathered from these studies will directly enhance our ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer.

Detailed Description

The first goal of this proposal is to collect cells from the peripheral blood, tumor draining lymph nodes and tumor infiltrating lymphocytes in patients with early or late stage gastrointestinal cancers. These samples will be evaluated in a variety of immunological assays to better understand the immune response to these two cancers. The second goal of this proposal is to evaluate using novel proteomic, cellomic, and genomic techniques the serum and peripheral blood lymphocytes of these patients for protein, cellular changes and genetic markers that correlate with the presence of cancer. The information gathered from these studies will directly enhance our ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
February 17, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amer Zureikat

Assistant Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • histologically confirmed GI malignancy
  • suspected GI malignancy
  • high risk individual as assessed by their physician

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The first goal of this proposal is to collect cells from the peripheral blood, tumor draining lymph nodes and tumor infiltrating lymphocytes in patients with early or late stage gastrointestinal cancers.

Time Frame: 1 N/A

Secondary Outcomes

  • The second goal is to evaluate using novel proteomic, CellomicTM, and genomic techniques the serum and peripheral blood lymphocytes of these patients for protein, cellular changes and genetic markers that correlate with the presence of cancer.(1 N/A)

Study Sites (1)

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