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

Open (Enrolling)
Communicable Disease, Immunologic Deficiency Syndrome, Neoplasm

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Trial Information

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


- 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

- Advances in the characterization of acquired genetic changes in tumor samples has

led to insights for the development of targeted therapy of malignancy


- 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, lymph node and bone marrow biopsies on patients
with immunodeficiency or cancer to investigate the immune system.


- Subjects with cancer.

- Subjects with immunodeficiency.

- Subjects with HTLV-1 infection.


-This is a natural history study that permits tissue acquisition for analysis of the immune
system and HTLV-1 infection.

Inclusion Criteria


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

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

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

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

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 DTM
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.

Type of Study:


Study Design:


Principal Investigator

Thomas A Waldmann, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

Related Keywords:

  • Communicable Disease
  • Immunologic Deficiency Syndrome
  • Neoplasm
  • Immunodeficiency
  • Genes
  • Metabolism
  • Infection
  • Diagnosis
  • Neoplasms
  • Communicable Diseases
  • Infection
  • Immunologic Deficiency Syndromes



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892