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CompletedNCT00898469Updated May 11, 2016

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

An observational study in Leukemia, sponsored by Children's Oncology Group. Completed. Open to participants aged 10 Years to 120 Months. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
671
Ages
10 Years to 120 Months
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Leukemia

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Keywords

  • childhood acute lymphoblastic leukemia
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 671 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 120 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients who received intensive therapy for acute lymphoblastic leukemia on clinical trial CCG-1882.

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
671 participants (estimated)
Patient registry
No

Interventions

  • Geneticpolymorphism analysis
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What researchers measure

Primary outcomes

  1. Identification of possible pharmacogenetic risk factors for avascular necrosis

    Time frame: length of study

  2. 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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00898469
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Mar 2005
Primary completion
May 2016
Completion
May 2016
Last update
May 11, 2016

Study contacts

Mary Relling, PharmD
study chair · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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