Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006342
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2000-10-04
Brief Title:
Genetic Study in Patients Receiving Treatment for Hodgkins Disease or Childhood Brain Tumor
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Analyses of Mutations Associated With Secondary Leukemia or Non-Hodgkins Lymphoma in Patients Treated for Hodgkins Disease or Childhood Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Determination of genetic markers for leukemia or non-Hodgkins lymphoma that is secondary to Hodgkins 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 Hodgkins disease or childhood brain tumors
PURPOSE Clinical trial to determine the presence of certain genes in patients who are receiving treatment for Hodgkins disease or childhood brain tumors
Detailed Description:
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 Hodgkins disease treated with radiotherapy andor chemotherapy II Determine the frequency of these aberrations in patients with pediatric central nervous system tumors treated with radiotherapy andor chemotherapy III Determine the glutathione-S-transferase allotype associated with human toxicological response to carcinogen exposure for these patients IV Determine the frequency of t1418 gene rearrangement associated with deregulation of the bcl-2 proto-oncogene in non-Hodgkins 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 andor 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 t1418 gene rearrangements
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 2 years
OUTLINE An extra tube of blood is collected before every 4 weeks during and every 3 months after radiotherapy andor 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 t1418 gene rearrangements
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DUMC-0113-99-1R2 | None | None | None |
| DUMC-IRB-086-97-1 | None | None | None |
| NCI-G00-1840 | None | None | None |