Development of Early Detection Signs for Gastrointestinal Cancer - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00633334

Purpose

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.

Condition	Intervention
GI Cancer	Other: Specimen bank

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Investigation of the Immune Response to Gastrointestinal Tumors and Development of Novel Biomarkers for the Presence of Gastrointestinal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 N/A ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

peripheral blood portions of tumor tumor draining lymph nodes

Estimated Enrollment:	1500
Study Start Date:	September 2003
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Potential research subjects are first identified by their primary doctor/clinical team. The research project will be discussed and mutually agreed upon between the subject and his/her caregiver before the research team will contact the subject. Other subjects are referred in specifically for possible participation in a particular study which they or their physician are aware of based on publications which list clinical trials at UPMCHS.

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633334

Contacts

Contact: Herbert J. Zeh, MD	412-692-2852	zehh@upmc.edu
Contact: Amy R Schmotzer, RN, BSN	(412) 647-6205	schmotzerar@upmc.edu

Locations

United States, Pennsylvania
University of Pittsburgh Cancer Institute	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Herbert J. Zeh, MD 412-692-2852 zehh@upmc.edu

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Herber J. Zeh, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh Medical Center ( Herbert J. Zeh, III, MD )
Study ID Numbers:	02-077
Study First Received:	March 3, 2008
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00633334 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Cancer
GI
Tumor
Gastrointestinal
high risk

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site

Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009