Screening Individuals and Families at High Risk for Hematologic Cancers - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052234

Purpose

RATIONALE: Evaluating genetic and environmental factors in individuals and families at high risk of developing hematologic cancer may help doctors plan more effective treatments.

PURPOSE: Screening trial to determine if genetic and environmental factors contribute to the development of hematologic cancer in individuals and families at high risk for cancer.

Condition	Intervention
Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Genetic: genetic linkage analysis Genetic: microarray analysis Other: counseling intervention Other: laboratory biomarker analysis Other: questionnaire administration Procedure: evaluation of cancer risk factors

Study Type:	Observational
Official Title:	Clinical, Laboratory And Epidemiologic Characterization Of Individuals And Families At High Risk Of Hematologic Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	3000
Study Start Date:	June 2002
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Ascertain individuals at high risk for hematologic malignancy because of personal or family medical history.
Evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing these individuals and families to hematologic cancer.
Evaluate the potential precursor states of malignancy in families at risk.
Quantify the risks of specific tumors in family members of this high-risk population and define syndromic constellations.
Identify, map, characterize, clone, and determine function of tumor susceptibility genes in this high-risk population.
Validate and test associations of biomarkers with risk in these individuals.
Identify genetic determinants, environmental factors, and gene-environmental interactions conferring cancer risk in individuals and families.
Identify differences and similarities between the familial and sporadic condition in this high-risk population.
Educate and counsel study participants about their risk of hematologic malignancy including prevention recommendations and early detection activities when known.

OUTLINE: One family member completes a family history questionnaire. Participants may undergo limited physical exams, imaging studies, and skin or bone marrow biopsy.

Blood is collected for localizing genetic loci, identifying genes, and evaluating genotype/phenotype correlations. Buccal cells are obtained for germline DNA extraction.

Participants receive counseling and education for cancer prevention, risk reduction, and early detection.

Participants are followed approximately annually for as long as possible.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Meets one of the following criteria:
- Family or personal medical history of hematologic/lymphoproliferative malignancy of an unusual type, pattern, or number
- Known or suspected factor(s) predisposing to hematologic malignancy
- Genetic and/or congenital (e.g., birth defects, metabolic phenotype, chromosomal anomalies, or Mendelian traits associated with tumors)
- Environmental exposure (e.g., medications, occupation, radiation, diet, or infectious agents)
- Unusual demographic features (e.g., very young age at onset or multiple tumors)
Familial aggregation of any of the following:
- Chronic lymphocytic leukemia
- Waldenstrom's macroglobulinemia (WM)
- Non-Hodgkin's lymphoma
- Hodgkin's lymphoma
- Mixed hematologic and lymphoproliferative diseases
- Any other hematologic cancer
At least 2 living affected family members required for familial neoplasms
- For WM, one case plus a living first-degree relative with an autoimmune condition is required

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052234

Locations

United States, Maryland
NCI - Division of Cancer Epidemiology and Genetics	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Genetic Epidemiology Branch Referral Nurse 800-518-8474
NCI - Genetic Epidemiology Branch	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Mary L. McMaster, MD 301-496-4375 mm349q@nih.gov
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Neil E. Caporaso, MD

NCI - Genetic Epidemiology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Publications:

McMaster ML, Giambarresi T, Vasquez L, Goldstein AM, Tucker MA. Cytogenetics of familial Waldenstrom's macroglobulinemia: in pursuit of an understanding of genetic predisposition. Clin Lymphoma. 2005 Mar;5(4):230-4.

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.

Caporaso N, Marti GE, Goldin L. Perspectives on familial chronic lymphocytic leukemia: genes and the environment. Semin Hematol. 2004 Jul;41(3):201-6. Review.

Chatterjee N, Hartge P, Cerhan JR, Cozen W, Davis S, Ishibe N, Colt J, Goldin L, Severson RK. Risk of non-Hodgkin's lymphoma and family history of lymphatic, hematologic, and other cancers. Cancer Epidemiol Biomarkers Prev. 2004 Sep;13(9):1415-21.

Goldin LR, Pfeiffer RM, Gridley G, Gail MH, Li X, Mellemkjaer L, Olsen JH, Hemminki K, Linet MS. Familial aggregation of Hodgkin lymphoma and related tumors. Cancer. 2004 May 1;100(9):1902-8.

Goldin LR, Pfeiffer RM, Li X, Hemminki K. Familial risk of lymphoproliferative tumors in families of patients with chronic lymphocytic leukemia: results from the Swedish Family-Cancer Database. Blood. 2004 Sep 15;104(6):1850-4. Epub 2004 May 25.

Pfeiffer RM, Goldin LR, Chatterjee N, Daugherty S, Hemminki K, Pee D, X LI, Gail MH. Methods for testing familial aggregation of diseases in population-based samples: application to Hodgkin lymphoma in Swedish registry data. Ann Hum Genet. 2004 Sep;68(Pt 5):498-508.

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.

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.

Study ID Numbers:	CDR0000256894, NCI-02-C-0210
Study First Received:	January 24, 2003
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00052234 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

AIDS-related lymphoma
Hodgkin lymphoma during pregnancy
T-cell large granular lymphocyte leukemia
Waldenstrom macroglobulinemia
acute undifferentiated leukemia
adult Hodgkin lymphoma
adult T-cell leukemia/lymphoma
adult acute lymphoblastic leukemia
adult acute myeloid leukemia
adult diffuse large cell lymphoma
adult diffuse mixed cell lymphoma
adult diffuse small cleaved cell lymphoma
adult Burkitt lymphoma
adult immunoblastic large cell lymphoma
adult lymphoblastic lymphoma

anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
childhood Hodgkin lymphoma
childhood acute lymphoblastic leukemia
childhood non-Hodgkin lymphoma
childhood acute myeloid leukemia/other myeloid malignancies
chronic lymphocytic leukemia
chronic myelogenous leukemia
chronic myelomonocytic leukemia
cutaneous T-cell non-Hodgkin lymphoma
grade 1 follicular lymphoma
grade 2 follicular lymphoma
grade 3 follicular lymphoma
hairy cell leukemia
intraocular lymphoma

Additional relevant MeSH terms:

Precancerous Conditions
Hematologic Neoplasms
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Leukemia
Preleukemia
Neoplasms by Site
Pathologic Processes
Hemorrhagic Disorders
Syndrome
Cardiovascular Diseases
Lymphoma
Disease

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 09, 2009