Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor
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|ClinicalTrials.gov Identifier: NCT00006342|
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : October 15, 2015
RATIONALE: Determination of genetic markers for leukemia or non-Hodgkin's lymphoma that is secondary to Hodgkin's disease and childhood brain tumors may help doctors to identify patients who are at risk for these cancers.
PURPOSE: Clinical trial to determine the presence of certain genes in patients who are receiving treatment for Hodgkin's disease or childhood brain tumors.
|Condition or disease||Intervention/treatment|
|Brain and Central Nervous System Tumors Lymphoma||Genetic: chromosomal translocation analysis Genetic: gene rearrangement analysis Genetic: mutation analysis|
OBJECTIVES: I. Determine the frequency of chromosome 3, 11, and 21 aberrations in peripheral blood lymphocytes (PBL) specifically associated with acute myelogenous leukemia in patients with adult or pediatric Hodgkin's disease treated with radiotherapy and/or chemotherapy. II. Determine the frequency of these aberrations in patients with pediatric central nervous system tumors treated with radiotherapy and/or chemotherapy. III. Determine the glutathione-S-transferase allotype, associated with human toxicological response to carcinogen exposure, for these patients. IV. Determine the frequency of t(14;18) gene rearrangement, associated with deregulation of the bcl-2 proto-oncogene in non-Hodgkin's lymphoma, in PBL of these patients.
OUTLINE: An extra tube of blood is collected before, every 4 weeks during, and every 3 months after radiotherapy and/or chemotherapy. DNA is isolated from the blood sample and the GSTM1, GSTT1, and various cytochrome P (CYP) 450 genotypes are determined by polymerase chain reaction (PCR). Mononuclear leukocytes are analyzed for chromosome aberrations on chromosome numbers 3, 11, and 21. Pretreatment karyotype and frequency of translocations are determined for each patient. Peripheral blood lymphocyte DNA is also examined for t(14;18) gene rearrangements.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2 years.
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||Analyses of Mutations Associated With Secondary Leukemia or Non-Hodgkin's Lymphoma in Patients Treated for Hodgkin's Disease or Childhood Brain Tumors|
|Study Start Date :||January 1997|
|Actual Primary Completion Date :||September 2000|
|Actual Study Completion Date :||January 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006342
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Edward C. Halperin, MD||Duke Cancer Institute|