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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT01247584
Study type Observational
Source Children's Oncology Group
Contact
Status Completed
Phase N/A
Start date November 2010

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