Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Differences in overall survival
研究概览
简要总结
This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
详细描述
PRIMARY OBJECTIVES:
I. Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.
II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.
OUTLINE:
Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DNA samples available from patients meeting the following criteria:
- •Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
- •Patients with pre-B ALL, including responders vs non-responders in selected genotypes [hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)] and responders and non-responders regardless of genotype
- •Pediatric patients with AML registered on POG-9421
- •Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
- •Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
- •Pediatric patients enrolled on COG-9900 and other CCG or POG trials
排除标准
- 未提供
结局指标
主要结局
Differences in overall survival
时间窗: Up to 8 years
Evaluated using the log rank statistic.
Relapse-free survival
时间窗: Time from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 years
Evaluated using the logrank statistic.
Differences in induction outcome, dichotomized into complete remission or no remission
时间窗: Up to 8 years
Assessed with Pearson's chi square statistic test
Etiology of leukemia: Fisher's exact test
时间窗: Up to 8 years
Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.
Disease-free survival (DFS)
时间窗: Time from the end of induction to relapse or death, assessed up to 8 years
Evaluated using the log rank statistic.
Etiology of leukemia: Chi square test
时间窗: Up to 8 years
Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.
次要结局
未报告次要终点