Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||May 2016|
- Frequency of mutations
- Relapse-free survival
- Overall survival
- Difference in telomere length
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247584
|Principal Investigator:||Maria M. Gramatges, MD||Texas Children's Hospital|