Search / Trial NCT00001582

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

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

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 ...

Gender

All

Eligibility 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:
  • 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.

Attachments

readout_NCT00001582_2024-06-14.pdf

4.5 MB

NCT00001582_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Ongoing

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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