Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT00898469
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
Study Of Pharmacogenetic Risk Factors For Avascular Necrosis CCG 1882
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: