Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00039676

Purpose

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.

Condition
Lymphoma Leukemia

Study Type:	Observational
Official Title:	Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Leukemia Lymphoma

U.S. FDA Resources

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

Estimated Enrollment:	3000
Study Start Date:	June 2002

Detailed Description:

Background:

Persons may be prone to develop hematologic or lymphoproliferative cancer for a variety of reasons including: inherited predisposition of benign, premalignant, or malignant conditions; environmental exposures shared by family members; previous tumors or preneoplastic conditions; immune deficiency; or, stochastic processes
Investigations of individuals and families at high risk of cancer often lead to etiologic clues that may be important in the sporadic counterparts of these cancers in the general population
Identification of etiologically important genetic factors could inform chemoprevention trials, screening programs, and treatment of hematologic and lymphoproliferative cancers

Objectives:

To evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing to hematologic cancer
To evaluate potential precursor states of malignancy in families at risk
To quantify the risks of specific tumors in family members and define syndromic constellations
To identify, map, characterize, clone, and determine function of tumor susceptibility genes
To validate and test associations of biomarkers with risk
To identify genetic determinants, environmental factors, and gene-environmental interactions conferring cancer risk in individuals and families
To identify differences and similarities between the familial and sporadic condition
To educate and counsel study participants about their risk of hematologic malignancy including prevention recommendations and early detection activities when known
To develop syndrome specific educational materials for medical professionals and high-risk family members

Eligibility:

Persons of any age will be considered if
- there is a personal or family medical history of hematologic/lymphoproliferative malignancy of an unusual type, pattern, or number; or,
- there are known or suspected factor(s) predisposing to hematologic malignancy, either genetic or congenital factors, environmental exposure, or unusual demographic features
For familial neoplasms, two or more living affected cases among family members are generally required

Design:

This is a prospective study. Families are studied long-term using a cohort approach.
The study design and clinical evaluation vary by the specific type of familial neoplasm being studied
The overall approach to eligible families includes defining affection status, characterization of disease, localization of genetic loci, identification of genes, evaluation of phenotype/genotype correlations, estimation of risk of the disease associated with carrier status, and identification of other risk factors that modify penetrance (genetic, environmental, and host factors)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Chronic lymphocytic leukemia (CLL)
Waldenstrom's macroglobulinemia (WM)
Non-Hodgkin's Lymphoma (NHL)
Hodgkin disease (HD)
Mixed hematologic and lymphoproliferative diseases

EXCLUSION CRITERIA:

Referred individuals for whom reported diagnosis cannot be verified.
Referred individuals who decline informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039676

Contacts

Contact: NCI Referral Office

1-888-NCI-1937

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Goldin LR, Ishibe N, Sgambati M, Marti GE, Fontaine L, Lee MP, Kelley JM, Scherpbier T, Buetow KH, Caporaso NE. A genome scan of 18 families with chronic lymphocytic leukaemia. Br J Haematol. 2003 Jun;121(6):866-873.

Marti GE, Carter P, Abbasi F, Washington GC, Jain N, Zenger VE, Ishibe N, Goldin L, Fontaine L, Weissman N, Sgambati M, Fauget G, Bertin P, Vogt RF Jr, Slade B, Noguchi PD, Stetler-Stevenson MA, Caporaso N. 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, Prieto D, Hosack DA, Lempicki RA, Goldin LR, Raffeld M, Marti GE, Caporaso NE. Telomere length and heavy-chain mutation status in familial chronic lymphocytic leukemia. Leuk Res. 2002 Sep;26(9):791-4.

ClinicalTrials.gov Identifier:	NCT00039676 History of Changes
Obsolete Identifiers:	NCT00052234
Other Study ID Numbers:	020210, 02-C-0210
Study First Received:	June 6, 2002
Last Updated:	December 29, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Genetics
Risk Factors
Natural History

Lymphoma
Leukemia
Lymph Node Cancer

Additional relevant MeSH terms:

Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012