Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months.
研究概览
简要总结
This is a prospective, single-center, nonrandomized observational study to investigate the utility of urine lipoarabinomannan (LAM) as a test to identify individuals at very low risk for having a sputum culture positive for Nontuberculous Mycobacteria (NTM). The study is designed to evaluate if a urine test can eliminate the need for obtaining a sputum specimen to screen for NTM in individuals with Cystic Fibrosis (CF). The participants will be asked to provide 3 urine samples either in person or by mail over approximately 3 years. The 3 urine sample requests will be timed to coincide with their usual clinical care and routine sputum collection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained online or in person from the participant
- •Enrolled in the CFF Patient Registry (CFFPR)
- •Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
- •Diagnosis of CF consistent with the 2017 CFF Guidelines NTM culture status of negative (defined by a review of clinical and culture data with at least 3 years of clinical data available to review and at least one negative culture within the year prior to enrollment and no known history of previous positive cultures for pathogenic NTM)
排除标准
- •Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
结局指标
主要结局
To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months.
时间窗: From time enrollment to over the next 12 months
Correlation of a negative NTM sputum culture in the year following a negative urine LAM assay
次要结局
- To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting.(3 years)
- To determine the ability of the urine LAM assay to predict new positive NTM sputum culture over the next 12 months.(From time of enrollment to over the next 12 months)
- To determine the time between a positive LAM assay and a new positive NTM culture.(3 years)
研究者
Jerry A. Nick, M.D.
Director, Adult CF Program at National Jewish Health
National Jewish Health