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Development of Early Detection Signs for Gastrointestinal Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00633334
Enrollment
2499
Registered
2008-03-12
Start date
2003-09-30
Completion date
2016-02-17
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GI Cancer

Keywords

Cancer, GI, Tumor, Gastrointestinal, high risk

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.

Interventions

OTHERSpecimen bank

Patients will be asked to provide approximately 60-120 cc (4-8 tablespoons) of peripheral blood. Select patients who undergo surgical resection of their tumor will be asked to provide portions of the tumor and tumor draining lymph nodes for further analysis. In addition patients undergoing surgical resection may be asked to provide additional peripheral blood samples at time of routine follow-up (at least 4-6 weeks after initial blood draw and between subsequent draws).

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026