Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Study Of Pharmacogenetic Risk Factors For Avascular Necrosis CCG 1882|
- Identification of possible pharmacogenetic risk factors for avascular necrosis [ Time Frame: length of study ] [ Designated as safety issue: No ]
- 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 [ Time Frame: length of study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898469
|Study Chair:||Mary Relling, PharmD||St. Jude Children's Research Hospital|