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

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ClinicalTrials.gov Identifier: NCT00001582
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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.

Condition or disease
T-cell Lymphoma B-Cell Lymphoma ATL Myeloma

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection
Actual Study Start Date : June 7, 1997


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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.@@@
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001582


Contacts
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Contact: NCI Medical Oncology Referral Office (240) 760-6050 ncimo_referrals@nih.gov
Contact: Kevin C Conlon, M.D. (240) 760-6087 conlonkc@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kevin C Conlon, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00001582    
Obsolete Identifiers: NCT00899067
Other Study ID Numbers: 970143
97-C-0143
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 23, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Autoimmune Disorder
Immune System Evaluation
Human Response Investigation
Tissue Acquisition
Natural History
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases