A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- treatment outcome based on NTM-NET consensus statement
研究概览
简要总结
Background:
NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.
objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.
Methods:
- informed consents
- register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria
- follow up 6 months to 1year based on the clinical situation
Analysis:
- treatment outcome based on NTM-NET consensus statement
- exploration of biomarker for progression and monitoring of treatment response
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 or more than 20 years
- •diagnosed by ATS criteria for NTM pulmonary disease
排除标准
- •not specific
结局指标
主要结局
treatment outcome based on NTM-NET consensus statement
时间窗: At the end of the treatment or 12months after treatment
1. For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results 2. For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.
次要结局
- biomarker for disease progression: RNA sequence analysis(at the end of the treatment (through study completion, an average of 12 to 15month after treatment))
- biomarker for monitoring of treatment response: metabolomic analysis(at the end of the treatment (through study completion, an average of 12 to 15month after treatment))
- biomarker for disease progression: metabolomic analysis(at the end of the treatment (through study completion, an average of 12 to 15month after treatment))
- biomarker for monitoring of treatment response: RNA sequence analysis(at the end of the treatment (through study completion, an average of 12 to 15month after treatment))