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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898469
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.


Condition or disease Intervention/treatment
Leukemia Genetic: polymorphism analysis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 671 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 120 Months   (Child)
Sexes Eligible for Study:   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.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Mary Relling, PharmD St. Jude Children's Research Hospital
More Information
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Publications of Results:
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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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898469    
Other Study ID Numbers: AALL03B2
COG-AALL03B2 ( Other Identifier: Children's Oncology Group )
CDR0000304752 ( Other Identifier: Clinical Trials.gov )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Children's Oncology Group:
childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms