Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
Telomere Length and Telomerase Mutations in Pediatric 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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
Enrolled on CCG-2961 and meeting 1 of the following criteria:
- More than 35 days to recover to an ANC > 500/mm³ after any course of chemotherapy
- Consistently recovered < 35 days to an ANC > 500/mm³ after all courses of chemotherapy
- Available cryopreserved cell from diagnostic and end-of-therapy samples
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
---|
总生存期
|
无复发生存
|
Frequency of mutations
|
Difference in telomere length
|
合作者和调查者
调查人员
- 首席研究员:Maria M. Gramatges, MD、Baylor College of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- AAML11B2 (其他标识符:Children's Oncology Group)
- COG-AAML11B2 (其他标识符:Children's Oncology Group)
- NCI-2011-02846 (注册表标识符:CTRP (Clinical Trial Reporting Program))
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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