Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003863
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Diagnostic Study of Patients With Aggressive Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Genetic Changes in Diffuse Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-07
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 aggressive non-Hodgkins lymphoma may help identify patients with this disease and help predict the outcome of treatment
PURPOSE Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkins lymphoma
PURPOSE Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Estimate the proportions of patients with diffuse aggressive non-Hodgkins lymphoma who have rearrangements affecting the MYC BCL2 and BCL6 genes determined by fluorescent in situ hybridization overtly amplified chromosomal regions and nonrandom copy number changes of chromosomal regions determined by comparative genomic hybridization
Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes eg response to therapy failure-free survival and overall survival in these patients
Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease such as disease site nodal vs extranodal and stage in these patients
OUTLINE This is a multicenter study
Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission
Samples are examined for rearrangements in the MYC BCL2 BCL6 and IGH genes using fluorescent in situ hybridization DNA is examined by comparative genomic hybridization which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
Estimate the proportions of patients with diffuse aggressive non-Hodgkins lymphoma who have rearrangements affecting the MYC BCL2 and BCL6 genes determined by fluorescent in situ hybridization overtly amplified chromosomal regions and nonrandom copy number changes of chromosomal regions determined by comparative genomic hybridization
Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes eg response to therapy failure-free survival and overall survival in these patients
Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease such as disease site nodal vs extranodal and stage in these patients
OUTLINE This is a multicenter study
Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission
Samples are examined for rearrangements in the MYC BCL2 BCL6 and IGH genes using fluorescent in situ hybridization DNA is examined by comparative genomic hybridization which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
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 |
|---|---|---|---|
| CDR0000067027 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA076001 |
| U10CA076001 | NIH | None | None |
| CALGB-9764 | None | None | None |