Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882

Completed

• Conditions: Leukemia

• Registration Number: NCT00898469
• Lead Sponsor: Children's Oncology Group

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to bone tissue death.

PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.

Detailed Description

OBJECTIVES:

* Identify possible pharmacogenetic risk factors for avascular necrosis (AVN) in pediatric patients who received intensive therapy for acute lymphoblastic leukemia on clinical trial CCG-1882.

* Compare whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D receptor C/C start site genotype are more common among patients who developed AVN than among patients who did not.

OUTLINE: This is a retrospective, cohort, multicenter study. Patients are stratified according to gender and treatment regimen on clinical trial CCG-1882 (augmented vs regular Berlin-Frankfurt-Munster).

DNA is extracted from slides of blast samples that were previously obtained from patients treated on clinical trial CCG-1882. DNA genotyping is performed, and genotypes (proportion of population with variant alleles or frequency of variant alleles) are compared between patients who did and did not develop avascular necrosis.

PROJECTED ACCRUAL: A total of 671 tissue samples from patients (294 females and 377 males) will be accrued for this study.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of possible pharmacogenetic risk factors for avascular necrosis	length of study
Comparison of whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D receptor C/C start site genotype are more common among patients who developed avascular necrosis than among patients who did not	length of study