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Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568867
First Posted: December 6, 2007
Last Update Posted: April 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: Stanford University Alternate IRB Approval Number )
VAR0018 ( Other Identifier: Stanford University )
First Submitted: December 4, 2007
First Posted: December 6, 2007
Last Update Posted: April 11, 2011
Last Verified: April 2011