Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||July 6, 2013|
|Start Date ICMJE||July 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001582 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer|
|Official Title ICMJE||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.
led to insights for the development of targeted therapy of malignancy
-This is a natural history study that permits tissue acquisition for analysis of the immune system and HTLV-1 infection.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patient must meet at least one of these criteria:
Have suspected or known disorder of the immune system or malignancy
Be a known or potential carrier of genetically determined autoimmune disorder or immunodeficiency disease.
Specific i disorders may include but are not limited to: X-linked (severe combined immunodeficiency) SCID (c gamma deficiency), Autosomal recessive SCID, X-linked CD40 ligand deficiency, Common variable immunodeficiency, Ataxia-telangiectasia, Wiskott Aldrich syndrome, DiGeorge syndrome and Infection 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 is necessary for apheresis.
Overall Exclusion Criteria:
Pregnant or breast feeding women will not be eligible for any aspect of this protocol except phlebotomy
Children less than 18 years old are not eligible for lymph node or bone marrow biopsy
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:
Pediatric normal volunteers (less than 18 years) will not undergo apheresis.
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001582|
|Other Study ID Numbers ICMJE||970143, 97-C-0143|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP