Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample

NCT ID: NCT00568867

Last Updated: 2011-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Jeffrey A. Norton

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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97310

Identifier Type: OTHER

Identifier Source: secondary_id

VAR0018

Identifier Type: OTHER

Identifier Source: secondary_id

SU-11072007-830

Identifier Type: -

Identifier Source: org_study_id

NCT00507624

Identifier Type: -

Identifier Source: nct_alias

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