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Clinical Trials/NCT01247584
NCT01247584
Completed
Not Applicable

Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia

Children's Oncology Group0 sites234 target enrollmentNovember 2010
ConditionsLeukemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Children's Oncology Group
Enrollment
234
Primary Endpoint
Frequency of mutations
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

RATIONALE: Studying bone marrow samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES: * 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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Frequency of mutations

Relapse-free survival

Overall survival

Difference in telomere length

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