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Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00568867
First received: December 4, 2007
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to evaluate markers of immune response in human tumor samples.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA

tumor tissue sample


Enrollment: 300
Study Start Date: September 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Cancer immunotherapy has been shown to be effective in isolated instances, but ineffective in most patients. The reason for this inconsistency, and the conditions necessary for successful immunotherapy, are not well understood. Our studies in animal tumor models indicate that the effectiveness of IL-12-based immunotherapy depends upon the presence of a preexisting immune response to the tumor. The presence of T cell infiltrates and IFN-gamma expression in tumor indicate such an immune response. We therefore plan to evaluate the existing immune response in human tumor samples in an effort to identify those patients most likely to respond to therapy with IL-12.

  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

Any adult patient with a tumor who is scheduled to undergo surgery to either remove or biopsy the tumor.

Criteria

Inclusion Criteria:Any adult patient with a tumor who is scheduled to undergo surgery to either remove or biopsy the tumor.

Exclusion Criteria:Patients without tumor and pediatric patients (children) will be excluded.

  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: NCT00568867

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jeffrey A. Norton Stanford University
  More Information

No publications provided

Responsible Party: Jeffrey A. Norton, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00568867     History of Changes
Obsolete Identifiers: NCT00507624
Other Study ID Numbers: SU-11072007-830, 97310, VAR0018
Study First Received: December 4, 2007
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014