Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia
RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.
PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.
|Leukemia||Genetic: cytogenetic analysis Genetic: mutation analysis Other: laboratory biomarker analysis|
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients|
|Study Start Date:||March 1998|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
- Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.
OUTLINE: Patients are stratified by risk (standard vs high).
Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Patients are followed for at least 3 years.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003291
|Australia, Western Australia|
|Princess Margaret Hospital for Children|
|Perth, Western Australia, Australia, 6001|
|Study Chair:||Ursula R. Kees, PhD||Telethon Institute for Child Health Research|