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

NCT00001582 | Completed

• 2 other identifiers: 97014397-C-0143
• Study Type: observational
• Target: 902
• Locations: 1 country
• Sites: 1

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....

Conditions

T-cell Lymphoma; B-Cell Lymphoma; ATL; Myeloma

Keywords

Autoimmune Disorder; Immune System Evaluation; Human Response Investigation; Tissue Acquisition; Natural History

Outcome Measures

Primary Outcomes (1)

• Create Biobank

  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.

  Ongoing

Study Arms (1)

1

Suspected or known disorder of the immune system or cancer; or, known or potential carrier of autoimmune disorder or immunodeficiency disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary clinical patients/population with a suspected or known disorder of the immune system or cancer per the eligibility criteria.@@@

You may qualify if:

• Participants 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 greater than or equal to 18 years.
• Participant must be able to understand and sign informed consent.
• Participants 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.

You may not qualify if:

• Pregnant women will not be eligible for any aspect of this protocol.
• Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following:
• Congestive Heart Failure
• History of angina
• 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.)
• Poorly controlled hypertension (average baseline blood pressure greater than 160/90)
• History of a coagulation protein disorder.
• Pediatric patients (less than 18 years) will not undergo apheresis.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, tissue, bone marrow aspirate and biopsy

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, B-Cell; Neoplasms, Plasma Cell; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kevin C Conlon, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: June 7, 1997
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data will be available during the study and indefinitely. @@@@@@Genomic data will be available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Genomic data will be available once genomic data are uploaded per protocol GDS plan for as long as database is active.@@@@@@Genomic data will be made available via dbGaP through requests to the data custodians.

Locations

US (1)