NCT00003291

Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia

Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
GENETIC	cytogenetic analysis
GENETIC	mutation analysis
OTHER	laboratory biomarker analysis

Timeline

• Start date: 1998-03-01
• Primary completion: 2006-03-01
• First posted: 2003-01-27
• Last updated: 2014-08-08

Locations

1 site across 1 country: Australia