Development of Early Detection Signs for Gastrointestinal Cancer

Completed

• Conditions: GI Cancer

• Registration Number: NCT00633334
• Lead Sponsor: University of Pittsburgh

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Primary Completion: 2016-01-28
• Study Completion: 2016-02-17
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2499

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 N/A

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States