Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00767533
Status:
TERMINATED
Last Update Posted:
2016-07-22
First Post:
2008-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunobiology of Cancer
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Immunobiology of Cancer
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished).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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SU-10012008-1313 | OTHER | Stanford University alternate IRB Number | View |