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Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample

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ClinicalTrials.gov Identifier: NCT00568867
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : April 11, 2011
Sponsor:
Information provided by:
Stanford University

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

Condition or disease
Cancer

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.

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample
Study Start Date : September 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008



Biospecimen Retention:   Samples With DNA
tumor tissue sample


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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.


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

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 Posted: December 6, 2007    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011