DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00897507|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : September 12, 2017
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment
PURPOSE: This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: polymorphism analysis|
- Determine the role of single nucleotide polymorphisms (SNPs) in determining response to therapy in pediatric patients with acute lymphoblastic leukemia.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||January 2100|
|Estimated Study Completion Date :||January 2100|
- Role of single nucleotide polymorphisms (SNPs) in determining response to therapy [ Time Frame: length of study ]
- Comparison of the association between SNPs and treatment outcome and toxicity in patients enrolled on CCG-1891 vs CCG-1952 [ Time Frame: length of study ]
- SNPs role in drug metabolizing enzymes and the development of veno-occlusive disease in patients enrolled on CCG-1952 [ Time Frame: length of study ]
- Interactions between genotypes and other risk factors for treatment response [ Time Frame: length of study ]
- Prediction of treatment response and toxicity utilizing genetic information and clinical data [ Time Frame: length of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897507
|Study Chair:||Richard Aplenc, MD, MSCE||Children's Hospital of Philadelphia|