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Immunobiology of Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00767533
Recruitment Status : Terminated (PI left)
First Posted : October 7, 2008
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
To learn whether or not an Interferon defect in cell signaling, recently discovered in immune cells from melanoma patients as well as breast cancer patients, is common to all cancers.

Condition or disease
Neoplasms

Detailed Description:

BACKGROUND

We have previously demonstrated that tumor-specific T cells could be identified in >50% of patients with metastatic melanoma and these cells appeared to be rendered anergic in vivo [Nature Medicine 5:677, 1999]. Recently we discovered that there is a signaling defect in the Interferon (IFN) pathway in immune cells from melanoma patients [PLOS Medicine 4:897 2007]. Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished). We would like to expand our research to all types of cancer to determine whether these phenomena occur in different cancer types.

OBJECTIVES

Our primary objective is to determine whether there is an IFN signaling defect in different types of cancers and to determine what is causing this defect.

The second objective is to determine whether these PBMCs are rendered anergic.

INVESTIGATIONAL PLAN

The study population will consist of patients who have been diagnosed with cancer, regardless of sex or ethnicity. Blood will be collected during the subjects regularly scheduled laboratory appointment and peripheral blood mononuclear cells (PBMCs) will be isolated for research purposes. These PBMCs will undergo studies, i.e. phosflow, qPCR, proliferation, survival, etc., to determine immune responses for T cells (CD4 and CD8), B cells (CD19), natural killer cells (CD16), and possibly monocytes (CD14).

Study Design
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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunobiology of Cancer
Study Start Date : October 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011
Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
peripheral blood mononuclear cells

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over.
Criteria
Inclusion Criteria:Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over. Exclusion Criteria:Participants who have an autoimmune disorder and/or are under the age of 18 years.
Contacts and Locations
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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): NCT00767533


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Peter P Lee Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00767533    
Other Study ID Numbers: VAR0033
SU-10012008-1313 ( Other Identifier: Stanford University alternate IRB Number )
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016