Immunobiology of Cancer

This study has been terminated.

(PI left)

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT00767533

First received: October 3, 2008

Last updated: July 20, 2016

Last verified: July 2016

History of Changes

Purpose

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
Neoplasms


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Immunobiology of Cancer

Further study details as provided by Stanford University:

Biospecimen Retention: Samples With DNA

peripheral blood mononuclear cells


Enrollment:	84
Study Start Date:	October 2008
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

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 Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished).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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767533

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Peter P Lee	Stanford University

More Information


Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT00767533 History of Changes
Other Study ID Numbers:	VAR0033 SU-10012008-1313 ( Other Identifier: Stanford University alternate IRB Number )
Study First Received:	October 3, 2008
Last Updated:	July 20, 2016

ClinicalTrials.gov processed this record on June 29, 2017

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