Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia
NCT ID: NCT00003291
Last Updated: 2014-08-08
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
200 participants
OBSERVATIONAL
1998-03-31
Brief Summary
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PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.
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Detailed Description
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* Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
* Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.
OUTLINE: Patients are stratified by risk (standard vs high).
Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Patients are followed for at least 3 years.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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cytogenetic analysis
mutation analysis
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed acute lymphoblastic leukemia (ALL)
* Meets criteria for 1 of the following:
* Standard risk, as defined by the following:
* 1 to 10 years old at diagnosis
* WBC less than 50,000/mm\^3
* High risk, as defined by the following:
* Less than 1 year old or over 10 years old at diagnosis
* WBC greater than 50,000/mm\^3
* Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)
PATIENT CHARACTERISTICS:
Age:
* See Disease Characteristics
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
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
17 Years
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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Ursula R. Kees, PhD
Role: STUDY_CHAIR
Telethon Institute for Child Health Research
Locations
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Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Countries
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Other Identifiers
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COG-B969
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-B969
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066224
Identifier Type: OTHER
Identifier Source: secondary_id
B969
Identifier Type: -
Identifier Source: org_study_id
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