Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT01533168
Last Updated: 2016-05-18
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
12 participants
OBSERVATIONAL
2012-02-29
Brief Summary
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PURPOSE: This research trial studies a genetic test in identifying previously undetectable minimal residual disease in cell samples from younger patients with acute lymphoblastic leukemia.
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Detailed Description
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* To identify and characterize changes in clonal populations of B cells in children with acute lymphoblastic leukemia (ALL) at diagnosis and Day 29 of induction.
* To define the ability of this technology to reclassify patients as minimal residual disease (MRD) positive at Day 29 of induction.
* To determine whether more sensitive detection of MRD at Day 29 would have clinical prognostic value in children with ALL.
OUTLINE: DNA extracted from diagnostic cells are analyzed for immunoglobulin heavy chain variable region by next-generation sequencing.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Interventions
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cytogenetic analysis
nucleic acid sequencing
diagnostic laboratory biomarker analysis
laboratory biomarker analysis
medical chart review
Eligibility Criteria
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Inclusion Criteria
* Samples from patients enrolled on COG-AALL0232 with standard-risk (SR) or high-risk (HR) acute lymphoblastic leukemia (ALL) with varying levels of MRD and relapse
* Diagnostic cells and Day 29 cells from patients that have not relapsed and are 5 years from diagnosis on protocol COG-AALL0232
* Diagnostic cells and Day 29 cells from patients that are matched for age, sex, initial white blood cell (WBC) count, and cytogenetics that have relapsed
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
1 Year
30 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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Norman J. Lacayo, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Other Identifiers
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COG-AALL12B1
Identifier Type: -
Identifier Source: secondary_id
CDR0000724799
Identifier Type: -
Identifier Source: secondary_id
AALL12B1
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00246
Identifier Type: REGISTRY
Identifier Source: secondary_id
AALL12B1
Identifier Type: -
Identifier Source: org_study_id
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