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

Disease Information

Descriptive Information
Brief Title † Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer
Official Title † Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection
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 have 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 Objective: - 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 Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Create Biobank
Secondary Outcome Measure †
Condition † T-cell Lymphoma B-Cell Lymphoma ATL Myeloma
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 1000
Start Date † July 8, 1997
Completion Date
Primary Completion Date
Eligibility Criteria † - INCLUSION CRITERIA: Patient must meet at least one of these criteria: Have suspected or known disorder of the immune system or cancer Be a known or potential carrier of autoimmune disorder or immunodeficiency disease. Specific disorders may include but are not limited to: - X-linked (severe combined immunodeficiency) - Autosomal recessive SCID - X-linked CD40 ligand deficiency - Common variable immunodeficiency - Ataxia-telangiectasia - Wiskott Aldrich syndrome - DiGeorge syndrome - Infection with HTLV-1 Age of birth and above for patients with suspected or known disorders of the immune system or cancer. Patient (or parent/guardian of a minor child) must be able to understand and sign informed consent. Patients who will undergo apheresis must have hematocrit greater than 28%, and platelet count greater than 50,000. Subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a Department of Transfusion Medicine consult physician. Weight greater than 25 kg is necessary for apheresis. EXCLUSION CRITERIA: Overall Exclusion Criteria: Pregnant women will not be eligible for any aspect of this protocol Children less than 18 years old are not eligible for lymph node or bone marrow biopsy Exclusion Criteria for skin/parenteral antigen tests: Any history of severe reaction or allergy to a particular skin test antigen or other ingredients in the formulation (e.g. Thimerosal, eggs or avian protein) will exclude a subject from receiving that particular skin test. Children under the age of 2 years are not eligible to receive the Pneumococcal polyvalent vaccine. Subjects under the age of 18 years are not eligible to receive the Candida skin test antigens. Exclusion Criteria for Apheresis Alone: Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the patient should not have any of the following: 1. Congestive Heart Failure 2. History of angina 3. Severe hypotension (at the discretion of the patient'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.
Gender All
Ages 1 Year - 99 Years
Accepts Healthy Volunteers No
Contacts †† Maureen E Edgerly, R.N., (240) 760-6050,
Location Countries † United States
Administrative Information
NCT ID † NCT00001582
Organization ID 970143
Secondary IDs †† 97-C-0143
Responsible Party Sponsor
Study Sponsor † National Cancer Institute (NCI)
Collaborators ††
Investigators † Principal Investigator: Thomas A Waldmann, M.D., National Cancer Institute (NCI)
Information Provided By
Verification Date January 31, 2017
First Received Date † November 3, 1999
Last Updated Date June 10, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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