DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia
Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL
5 other identifiers
observational
520
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2004
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2016
CompletedAugust 15, 2022
October 1, 2017
12 years
May 9, 2009
August 12, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Leukemia Relapse
Contingency tables will be used to tabulate the relationship between relapse and genotype, race, leukemia cytogenetics, day 7 bone marrow status, and treatment arm
Day 7
Development of veno-occlusive disease in patients on CCG-1952
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
Day 28
Development of a predictive model of leukemia relapse
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response
Day 28
Development of a predictive model of leukemia toxicity
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment toxicity.
Day 28
Secondary Outcomes (1)
Development of grade III/IV toxicity as defined by the CCG toxicity criteria
Day 28
Study Arms (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Childrens Oncology Group
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Aplenc
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
May 13, 2004
Primary Completion
May 5, 2016
Last Updated
August 15, 2022
Record last verified: 2017-10