Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer

Completed

• Conditions: B-Cell Lymphoma; ATL; Myeloma; T-cell Lymphoma

• Registration Number: NCT00001582
• Lead Sponsor: National Cancer Institute (NCI)

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 and/or 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 Timeline

• Study Start: 1997-06-07
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Status Verified: 2023-03
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-17
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 902

Inclusion Criteria

Not provided

Exclusion Criteria

Pregnant women will not be eligible for any aspect of this protocol.

Exclusion Criteria for Apheresis Alone:

Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following:

1. Congestive Heart Failure
2. History of angina
3. Severe hypotension (at the discretion of the participant's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTM Standard Operating Policies.)
4. Poorly controlled hypertension (average baseline blood pressure greater than 160/90)
5. History of a coagulation protein disorder.

Pediatric patients (less than 18 years) will not undergo apheresis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Create Biobank	Ongoing	No statistical endpoints are identified for this study; the purpose of the study is to acquire information regarding various immunodeficiency syndromes, HTLV-1 infection and malignancies. The data collected will not be combined for a summary report of the entire study; however, reports for specific disease entities may be published.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States