Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001582
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
1999-11-03
Brief Title:
Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Blood Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response Lymphoma Biology and HTLV-1 Infection
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is being submitted to consolidate update and expand two previously approved protocols 77-C-0066 and 82-C-0044 into a single protocol The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal unrelated individuals will also be studied A small number of procedures will be used including analysis of blood obtained by phlebotomy apheresis skin testing and recall antigens and immunization to assess humoral immunity
Detailed Description:
Background
The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years
Blood obtained by apheresis or blood drawing skin biopsies and other tissues will be evaluated for abnormalities related to immunity HTLV-1 infection and the immune system
Advances in the characterization of acquired genetic changes in tumor samples has
led to insights for the development of targeted therapy of malignancy
Objectives
To characterize the molecular biology and immunological features as well as the clinical course of individuals with suspected or known disorders of the immune system or cancer
To define the nature of the immunological genetic and epigenetic abnormalities in the cells of patients with immunodeficiency diseases associated with infections andor a high incidence of malignancy and in patients with cancer
To obtain whole blood plasma and leukocytes as well as skin lymph node and bone marrow biopsies on patients with immunodeficiency or cancer to investigate the immune system
Eligibility
Subjects with cancer
Subjects with immunodeficiency
Subjects with HTLV-1 infection
Design
-This is a natural history study that permits tissue acquisition for analysis of the immune system and HTLV-1 infection
The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years
Blood obtained by apheresis or blood drawing skin biopsies and other tissues will be evaluated for abnormalities related to immunity HTLV-1 infection and the immune system
Advances in the characterization of acquired genetic changes in tumor samples has
led to insights for the development of targeted therapy of malignancy
Objectives
To characterize the molecular biology and immunological features as well as the clinical course of individuals with suspected or known disorders of the immune system or cancer
To define the nature of the immunological genetic and epigenetic abnormalities in the cells of patients with immunodeficiency diseases associated with infections andor a high incidence of malignancy and in patients with cancer
To obtain whole blood plasma and leukocytes as well as skin lymph node and bone marrow biopsies on patients with immunodeficiency or cancer to investigate the immune system
Eligibility
Subjects with cancer
Subjects with immunodeficiency
Subjects with HTLV-1 infection
Design
-This is a natural history study that permits tissue acquisition for analysis of the immune system and HTLV-1 infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-C-0143 | None | None | None |