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

March 17, 2023 updated by: National Cancer Institute (NCI)

Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection

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....

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

902

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.@@@

Description

  • INCLUSION CRITERIA:

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.

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Suspected or known disorder of the immune system or cancer; or, known or potential carrier of autoimmune disorder or immunodeficiency disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Create Biobank
Time Frame: 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.
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 1997

Primary Completion (Actual)

March 17, 2023

Study Completion (Actual)

March 17, 2023

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970143
  • 97-C-0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. @@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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