Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01247584|
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : May 19, 2016
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: DNA analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis|
- 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 Type :||Observational|
|Estimated Enrollment :||234 participants|
|Official Title:||Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia|
|Study Start Date :||November 2010|
|Primary Completion Date :||May 2016|
- Frequency of mutations
- Relapse-free survival
- Overall survival
- Difference in telomere length
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247584
|Principal Investigator:||Maria M. Gramatges, MD||Texas Children's Hospital|