DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Leukemia
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Retrospective
Participation Requirements
- Age
- Younger than 18 years
- Gender
- Both males and females
Description
OBJECTIVES: Primary Determine the role of single nucleotide polymorphisms (SNPs) in determining response to therapy in pediatric patients with acute lymphoblastic leukemia. Secondary Compare the association between SNPs and treatment outcome and toxicity in patients enrolled on protocol CCG-1891 vs ...
OBJECTIVES: Primary Determine the role of single nucleotide polymorphisms (SNPs) in determining response to therapy in pediatric patients with acute lymphoblastic leukemia. Secondary Compare the association between SNPs and treatment outcome and toxicity in patients enrolled on protocol CCG-1891 vs protocol CCG-1952. Determine the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients enrolled on CCG-1952. Evaluate interactions between genotypes and other risk factors for treatment response in these patients. Determine predictive models utilizing genetic information and clinical data to predict treatment response and toxicity in these patients. OUTLINE: Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk. PROJECTED ACCRUAL: A total of 800 patients (200 with relapsed disease and 600 without relapsed disease) will be accrued for this study.
Tracking Information
- NCT #
- NCT00897507
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Study Chair: Richard Aplenc, MD, MSCE Children's Hospital of Philadelphia