Protocol Number: 02-C-0210

Title:

Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy

Number:

02-C-0210

Summary:

This study will try to discover how genetic and environmental factors contribute to the development of blood or lymph node cancer and related conditions.

Individuals of any age with a personal and family history of a hematologic (blood or lymph node) cancer of an unusual type, pattern, or number may be eligible for this study. Of particular interest are chronic lymphocytic leukemia, Waldenstrom's macroglobulinemia, non-Hodgkin's lymphoma, Hodgkin disease, and mixed hematologic and lymphoproliferative, meaning different LPDs appearing within a family (i.e. a family with 2 sisters with CLL) and lymphoproliferative diseases. Participants will have the following procedures:

- Fill out one or two questionnaires about their personal and family medical history

- Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with blood or lymph node cancer, tumors, or other related illnesses for whom they are the legally authorized representative

- Donate a blood or cheek cell sample or a lock of hair to be used for genetic studies.

In addition, patients may also be evaluated at the NIH Clinical Center for a complete medical history and physical examination, routine blood tests, urinalysis, and possibly some of the following tests:

- X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues - MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour.

- Cell surface marker test - White blood cells (or lymph nodes or bone marrow, if available) are tested to confirm the diagnosis of cancer and rule out other closely related conditions. The test is also done on family members to look for early changes that can indicate a risk of cancer in the family.

- Skin biopsy - The area of skin to be biopsied is numbed with a local anesthetic and a 1/4-inch piece of skin is removed with a cookie cutter-like instrument. The wound is then covered with a band aid.

- Bone marrow test - An area over the bony part of the lower back is numbed with a local anesthetic. A needle is then inserted and a few teaspoons of blood from the bone is withdrawn, along with a tiny sliver of bone. This provides information about the ability of the bone marrow to produce blood cells.

- Leukapheresis - This is a procedure for collecting large quantities of white blood cells. Whole blood is withdrawn through a needle placed in an arm vein, similar to donating blood, and channeled into a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the donor through a needle in the other arm.

- Fluorescein angiography - A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina-a thin layer of tissue that lines the back of the eye-are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.

When the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

On referral, persons of any age will be considered for inclusion in the study because of either:

A family or personal medical history of hematologic/ lymphoproliferative malignancy of any unusual type, pattern, or number; or,

Known or suspected factor(s) predisposing to hematologic malignancy, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset multiple tumors, etc.).

Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records.

For familial neoplasms, two or more living affected cases among family members are generally required, although in selected instances exceptions may be made, e.g., for WM, one cases plus a living 1st degree relative with an autoimmune condition will qualify a family for further investigations.

Familial aggregation of any hematologic cancer(s) is eligible for study, our current active accrual efforts fall into 5 categories

1. Chronic lymphocytic leukemia (CLL)

2. Waldenstrom's macroglobulinemia (WM)

3. Non-Hodgkin's Lymphoma (NHL)

4. Hodgkin disease (HD)

5. Mixed hematologic and lymphoproliferative diseases

EXCLUSION CRITERIA:

Referred individuals for whom reported diagnosis cannot be verified.

Referred individuals who decline informed consent.

Special Instructions: Currently Not Provided

Keywords:

Genetics

Risk Factors

Natural History

Lymphoma

Leukemia

Recruitment Keywords:

Lymph Node Cancer

Lymphoma

Leukemia

Conditions:

Lymphoma

Leukemia

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Goldin LR, et al., A genome scan of 18 families with chronic lymphocytic leukaemia. Br J Haematol. 2003 Jun;121(6):866-873. PMID: 12786797

Marti GE, et al., B-cell monoclonal lymphocytosis and B-cell abnormalities in the setting of familial B-cell chronic lymphocytic leukemia. Cytometry. 2003 Mar;52B(1):1-12. PMID: 12599176

Ishibe N, et al., Telomere length and heavy-chain mutation status in familial chronic lymphocytic leukemia. Leuk Res. 2002 Sep;26(9):791-4. PMID: 12127552

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/27/2004