NIH Clinical Research Studies

Protocol Number: 02-C-0210

Active Accrual, Protocols Recruiting New Patients

Title:
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy
Number:
02-C-0210
Summary:
Background:

-Individuals may be prone to develop blood or lymph node cancers (leukemia or lymphoma) for a variety of reasons, including genetic predisposition to these cancers, environmental exposures or other medical conditions.

-Studies of people and families at high risk of cancer often lead to clues about their cause that may also be important regarding the sporadic occurrence of these cancers in the general population.

-Identifying genetic or environmental factors that play a role in the development of these diseases may be important in developing prevention trials, screening programs and treatments.

Objectives:

-Describe the cancers and other conditions in families with blood or lymph node cancer.

-Find and describe genes that may cause blood and lymph node cancer, and understand how they work in families.

-Use laboratory methods to try to determine if it is possible to identify who is at highest risk of blood or lymph node cancer.

-Test how genes act with other factors to alter the risk of disease, its severity or its manifestations in families.

Eligibility:

-Individuals of any age with a personal or family history of a blood or lymph node cancer.

-Individuals with a personal or family history of medical conditions or environmental exposures that may predispose to blood or lymph node cancer.

Design:

-Participants complete questionnaires about their personal and family medical history and provide 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.

-Participants donate a sample of blood or cheek cells, or a lock of hair for genetic studies.

-Patients may also be evaluated at the NIH Clinical Center by one or more of the following specialists: cancer doctor or blood specialist, medical geneticist, research nurses or clinical social worker. They may have blood and urine tests and a cheek swab or mouth wash to collect cheek cells. Some patients may also be asked to have x-rays and routine imaging, such as CT scans or ultrasound tests, cell surface markers, skin biopsy, and, with special consents, bone marrow biopsy, MRI or PET scans, apheresis or fluorescein angiography and photography.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled
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 Keyword(s):
Lymph Node Cancer
Lymphoma
Leukemia
Condition(s):
Lymphoma
Leukemia
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Cancer Institute

Contact(s):
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

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

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.

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

Active Accrual, Protocols Recruiting New Patients

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