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Immunobiology of Cancer
This study is currently recruiting participants.
Verified by Stanford University, October 2008
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00767533
  Purpose

The purpose of this study is 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 Intervention
Carcinomas
Procedure: Phlebotomy

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Immunobiology of Cancer

Further study details as provided by Stanford University:

Estimated Enrollment: 250
Study Start Date: October 2008
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 Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished).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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767533

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Diana Simons     650-498-7943     dlsimons@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Peter P Lee            
Sub-Investigator: Heather A. Wakelee            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Peter P Lee Stanford University
  More Information

Study ID Numbers: SU-10012008-1313, VAR0033
Study First Received: October 3, 2008
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00767533  
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Carcinomas (including Squamous Cell and Adenocarcinoma)

Study placed in the following topic categories:
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009