Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
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.
|Leukemia||Genetic: DNA analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis|
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia|
- Frequency of mutations
- Relapse-free survival
- Overall survival
- Difference in telomere length
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2010|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247584
|Principal Investigator:||Maria M. Gramatges, MD||Texas Children's Hospital|