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Development of Early Detection Signs for Gastrointestinal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00633334
First received: March 3, 2008
Last updated: May 20, 2014
Last verified: May 2014

March 3, 2008
May 20, 2014
September 2003
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00633334 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

peripheral blood portions of tumor tumor draining lymph nodes

Non-Probability Sample

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.

GI Cancer
Other: Specimen 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).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • histologically confirmed GI malignancy
  • suspected GI malignancy
  • high risk individual as assessed by their physician
Both
18 Years and older
No
Contact: Herbert J. Zeh, MD 412-692-2852 zehh@upmc.edu
Contact: Gail Tribble, RN, BSN 412-647-8205 tribbleg@upmc.edu
United States
 
NCT00633334
02-077
Yes
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Herber J. Zeh, MD University of Pittsburgh
University of Pittsburgh
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP