Target Gene Sequencing for Advanced Stage, Relapsed/Refractory Natural Killer/T-cell Lymphoma and the Correlation Between Gene Abmormalities and Chemotherapy Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Concordance
研究概览
简要总结
Although modern radiation techniques combined with chemotherapy has greatly improved the local control and long-term survivals for patients with early-stage NKTCL, relapse and systemic dissemination are common for localized patients. Relapsed/refractory diseases together with advanced stage NKTCLs uaually progress rapidly with poor prognosis (5-year overall survival rate, 0-20%). According to published studies, some recurrent genetic alternations have been identified in NKTCL, including oncogene/tumor suppressive gene abberants, epigenetic changes, cellular signaling pathways abnormalities, cellular apoptosis related genes and so forth. However, the gene profiling techniques and materials vary in different studies, no consensus has been reached on the gene abnormalities of advanced, or relapsed/refractory NKTCL up to now. Additionally, gene sequencing using ctDNA of peripheral blood has been unexploited in NKTCL patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
- •stage III/IV disease; or relapsed or refractory disease after at least one line prior teratment;
- •age ≥ 18 years;
- •ECOG performance status 0-2;
- •at least one measurable lesion;
- •adequate hematological, hepatic, and renal functions;
- •life expectancy of more than 3 months.
排除标准
- •Previously untreated stage I/II disease;
- •with no adequate tumour tissue;
- •any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
结局指标
主要结局
Concordance
时间窗: 2 years
The concordance of plasma cfDNA genotyping and tumor genotyping is defined as the ratio of gene variants detected in tumor and cfDNA to variants identified in tumor
次要结局
未报告次要终点
研究者
Mei Dong
Principal Investigator
Chinese Academy of Medical Sciences