Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882
NCT ID: NCT00898469
Last Updated: 2016-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
671 participants
OBSERVATIONAL
2005-03-31
2016-05-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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polymorphism analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute lymphoblastic leukemia (ALL)
* Has diagnostic ALL blast sample slides available for DNA extraction
* Previously treated on clinical trial CCG-1882
PATIENT CHARACTERISTICS:
Age
* 10 and over at diagnosis
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
10 Years
120 Months
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Mary Relling, PharmD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
References
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Hamilton LH, Mattano LA, Sather HN, et al.: A SERPINE1 (PAI-1) single nucleotide polymorphism predicts osteonecrosis in children treated for acute lymphoblastic leukemia: results of the Childrens Oncology Group (COG) study AALL03B2. [Abstract] Blood 108 (11): A-709, 2006.
Other Identifiers
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COG-AALL03B2
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000304752
Identifier Type: OTHER
Identifier Source: secondary_id
AALL03B2
Identifier Type: -
Identifier Source: org_study_id
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