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NCT Number: NCT00897507

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

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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Key information

Conditions

Childhood Acute Lymphoblastic Leukemia in Remission Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Leukemia Relapse

    Time frame: Day 7

    Contingency tables will be used to tabulate the relationship between relapse and genotype, race, leukemia cytogenetics, day 7 bone marrow status, and treatment arm

  2. Development of veno-occlusive disease in patients on CCG-1952

    Time frame: Day 28

    Classification and Regression Trees (CART), genotype patterning, Multifactor Dimensionality Reduction (MDR) techniques will be used to identify SNP combinations associated with risk of relapse and VOD

  3. Development of a predictive model of leukemia relapse

    Time frame: Day 28

    Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response

  4. Development of a predictive model of leukemia toxicity

    Time frame: Day 28

    Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment toxicity.

Secondary outcomes

  1. Development of grade III/IV toxicity as defined by the CCG toxicity criteria

    Time frame: Day 28

    Contingency tables will be used to tabulate categorical toxicities and toxicity severity grade.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL

Important dates

Study start
2004
Primary completion
2016
First posted
May 12, 2009
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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