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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052234 |
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 |
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Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Procedure: counseling Procedure: evaluation of cancer risk factors Procedure: gene expression profiling Procedure: genetic linkage analysis Procedure: laboratory biomarker analysis Procedure: questionnaire administration |
Study Type: | Observational |
Official Title: | Clinical, Laboratory And Epidemiologic Characterization Of Individuals And Families At High Risk Of Hematologic Cancer |
Estimated Enrollment: | 3000 |
Study Start Date: | June 2002 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Familial aggregation of any of the following:
At least 2 living affected family members required for familial neoplasms
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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 |
Study Chair: | Neil E. Caporaso, MD | NCI - Genetic Epidemiology Branch |
Study ID Numbers: | CDR0000256894, NCI-02-C-0210 |
Study First Received: | January 24, 2003 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00052234 |
Health Authority: | Unspecified |
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 |
Juvenile myelomonocytic leukemia Sezary syndrome Chronic myelogenous leukemia Chronic myelomonocytic leukemia Primary effusion lymphoma Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Mycoses Preleukemia Hemorrhagic Disorders Leukemia, Prolymphocytic Multiple myeloma |
Lymphoma, AIDS-Related Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Acute myeloid leukemia, adult Hodgkin Disease Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Neoplasms Neoplasms by Site Pathologic Processes Disease |
Neoplasms by Histologic Type Immune System Diseases Syndrome Cardiovascular Diseases |