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Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), February 2009
First Received: November 3, 1999   Last Updated: June 17, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001582
  Purpose

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
Communicable Disease
Immunologic Deficiency Syndrome
Neoplasm

Study Type: Observational
Official Title: Investigation of the Human Immune Response and HTLV-1 Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: July 1997
Estimated Study Completion Date: April 2000
Estimated Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
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.

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 plasma, leukocytes and skin 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patient must have a suspected or known disorder of the immune system or malignancy, OR

Be a family member of a patient with a known or suspected immunodeficiency disease, OR

Be a known or potential carrier of genetically determined immunodeficiency disease.

Specific immunodeficiency disorders may include but are not limited to: X-linked SCID (severe combined immunodeficiency) (c gamma deficiency), autosomal recessive SCID, X-linked CD40 ligand deficiency, Common variable immunodeficiency, Ataxia-telangiectasia, Wiskott Aldrich syndrome, and the DiGeorge syndrome OR

Be infected with HTLV-1.

Age of birth and above for patients with suspected or known disorders of the immune system.

Patient (or parent/guardian of a minor child) must be able to understand and sign informed consent.

Hematocrit greater than 28%, and platelet count greater than 50,000 necessary for apheresis.

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 and adequate venous access (not requiring placement of a central catheter) are necessary for apheresis.

EXCLUSION CRITERIA:

Overall Exclusion Criteria:

Pregnant or breast feeding women will not be eligible for any aspect of this protocol except phlebotomy

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 or mumps 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 DTN Standard Operating Policies.)
  4. Poorly controlled hypertension (average baseline blood pressure greater than 160/90)
  5. History of a coagulation protein disorder.

Pediatric normal volunteers (less than 18 years) will not undergo apheresis.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001582

Contacts
Contact: NCI Referral Office 1-888-NCI-1937 ncicssc@mail.nih.gov
Contact: Suzanne Fioravanti, R.N. (301) 594-6544 fioravas@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 970143, 97-C-0143
Study First Received: November 3, 1999
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00001582     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunodeficiency
Genes
Metabolism
Infection
Diagnosis

Study placed in the following topic categories:
Human T Cell Leukemia Virus 1
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
Neoplasms
Pathologic Processes
Disease
Immune System Diseases
Syndrome
Infection
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009