Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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: Observational Model: Cohort
Time Perspective: 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:


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

peripheral blood portions of tumor tumor draining lymph nodes


Estimated Enrollment: 1500
Study Start Date: September 2003
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Herbert J. Zeh, MD 412-692-2852 zehh@upmc.edu
Contact: Gail Tribble, RN, BSN 412-647-8205 tribbleg@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
ClinicalTrials.gov Identifier: NCT00633334     History of Changes
Other Study ID Numbers: 02-077
Study First Received: March 3, 2008
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Cancer
GI
Tumor
Gastrointestinal
high risk

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014