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Clinical Trials (PDQ®)

Prospective Study of Clinical, Laboratory, Genetic, and Epidemiologic Characterization of Individuals and Families at High Risk for Hematologic Cancers

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Related Information
Registry Information

Alternate Title

Screening Individuals and Families at High Risk for Hematologic Cancers

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Educational/Counseling/Training, Genetics, Natural history/EpidemiologyActiveAny ageNCINCI-02-C-0210
NCT00052234

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Objectives

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

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Patient Characteristics:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Expected Enrollment

3000

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

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.

Published Results

McMaster ML, Giambarresi T, Vasquez L, et al.: Cytogenetics of familial Waldenstrom's macroglobulinemia: in pursuit of an understanding of genetic predisposition. Clin Lymphoma 5 (4): 230-4, 2005.[PUBMED Abstract]

Marti GE, Carter P, Abbasi F, et al.: B-cell monoclonal lymphocytosis and B-cell abnormalities in the setting of familial B-cell chronic lymphocytic leukemia. Cytometry 52B (1): 1-12, 2003.[PUBMED Abstract]

Related Publications

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

Chatterjee N, Hartge P, Cerhan JR, et al.: Risk of non-Hodgkin's lymphoma and family history of lymphatic, hematologic, and other cancers. Cancer Epidemiol Biomarkers Prev 13 (9): 1415-21, 2004.[PUBMED Abstract]

Goldin LR, Pfeiffer RM, Gridley G, et al.: Familial aggregation of Hodgkin lymphoma and related tumors. Cancer 100 (9): 1902-8, 2004.[PUBMED Abstract]

Goldin LR, Pfeiffer RM, Li X, et al.: Familial risk of lymphoproliferative tumors in families of patients with chronic lymphocytic leukemia: results from the Swedish Family-Cancer Database. Blood 104 (6): 1850-4, 2004.[PUBMED Abstract]

Pfeiffer RM, Goldin LR, Chatterjee N, et al.: Methods for testing familial aggregation of diseases in population-based samples: application to Hodgkin lymphoma in Swedish registry data. Ann Hum Genet 68 (Pt 5): 498-508, 2004.[PUBMED Abstract]

Goldin LR, Ishibe N, Sgambati M, et al.: A genome scan of 18 families with chronic lymphocytic leukaemia. Br J Haematol 121 (6): 866-73, 2003.[PUBMED Abstract]

Ishibe N, Prieto D, Hosack DA, et al.: Telomere length and heavy-chain mutation status in familial chronic lymphocytic leukemia. Leuk Res 26 (9): 791-4, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Neil Caporaso, MD, Protocol chair
Ph: 240-276-7228

Trial Sites

U.S.A.
Maryland
  Bethesda
 NCI - Division of Cancer Epidemiology and Genetics
 Genetic Epidemiology Branch Referral Nurse
Ph: 800-518-8474
 Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
 Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office
Ph: 888-NCI-1937
  Rockville
 NCI - Genetic Epidemiology Branch
 Mary McMaster, MD
Ph: 240-276-7230
  Email: mm349q@nih.gov

Related Information

Featured trial article

Registry Information
Official Title Clinical, Laboratory And Epidemiologic Characterization Of Individuals And Families At High Risk Of Hematologic Cancer
Trial Start Date 2002-06-03
Trial Completion Date 2012-12-31 (estimated)
Registered in ClinicalTrials.gov NCT00052234
Date Submitted to PDQ 2002-06-26
Information Last Verified 2007-04-05

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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