DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-13

Brief Summary

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This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment

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Detailed Description

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PRIMARY OBJECTIVE:

I. To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.

II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.

III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.

IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.

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.

Conditions

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Childhood Acute Lymphoblastic Leukemia in Remission Recurrent Childhood Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ancillary-Correlative (genotype assessment)

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.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Aplenc

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Childrens Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States