Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
NCT ID: NCT01247584
Last Updated: 2016-05-19
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
234 participants
OBSERVATIONAL
2010-11-30
Brief Summary
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PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.
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Detailed Description
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* To compare the frequency of germline telomerase mutations in pediatric patients with acute myeloid leukemia (AML) demonstrating prolonged myelosuppression, defined as ≥ 1 episode \> 35 days of neutrophil count recovery after chemotherapy, to the pediatric patients with the expected myelosuppression, defined as consistently \< 35 days of neutrophil count recovery after chemotherapy.
* To assess association between telomerase mutations and incidence of grade 3 or 4 mucositis, relapse, and death.
* To compare germline (remission) telomere length in pediatric AML patients demonstrating delayed bone marrow recovery with the pediatric patients with consistently expected recovery.
* To assess whether a correlation between telomere length and incidence of grade 3 or 4 mucositis, relapse, and death exist.
OUTLINE: This is a multicenter study.
Cryopreserved bone marrow samples are analyzed for DNA sequencing and mutation by Sanger-based sequencing methods, quantitative PCR, and SeqMan Pro (Lasergene from DNAStar). Results are then compared with previously published data and existing databases to determine the allele frequency in control populations.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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DNA analysis
mutation analysis
polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute myeloid leukemia
* Enrolled on CCG-2961 and meeting 1 of the following criteria:
* More than 35 days to recover to an ANC \> 500/mm³ after any course of chemotherapy
* Consistently recovered \< 35 days to an ANC \> 500/mm³ after all courses of chemotherapy
* Available cryopreserved cell from diagnostic and end-of-therapy samples
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
21 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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Maria M. Gramatges, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Other Identifiers
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COG-AAML11B2
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02846
Identifier Type: REGISTRY
Identifier Source: secondary_id
AAML11B2
Identifier Type: OTHER
Identifier Source: secondary_id
AAML11B2
Identifier Type: -
Identifier Source: org_study_id
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