Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882
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|ClinicalTrials.gov Identifier: NCT00898469|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 11, 2016
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: polymorphism analysis|
- 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 Type :||Observational|
|Estimated Enrollment :||671 participants|
|Official Title:||Study Of Pharmacogenetic Risk Factors For Avascular Necrosis CCG 1882|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Identification of possible pharmacogenetic risk factors for avascular necrosis [ Time Frame: 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 [ Time Frame: length of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898469
|Study Chair:||Mary Relling, PharmD||St. Jude Children's Research Hospital|