PAINLESS: Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Adults with a diagnosis of CF with history of negative NTM sputum cultures Male or female participants age 18 or greater at time of enrollment with diagnosis of CF consistent with the 2017 CFF Guidelines and NTM culture status of negative, as defined by a review of at least 3 year or more years of culture data and at least 3 NTM negative cultures with one of those negative cultures being within the last 3 years and no known history of previous positive cultures for pathogenic NTM by chart review. |
Diagnostic Test: urine lipoarabinomannan (LAM)
Investigate the utility of urine LAM as a test to identify individuals at very low risk for having a sputum culture positive for NTM.
|
Outcome Measures
Primary Outcome Measures
- To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months. [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
Secondary Outcome Measures
- 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]
Correlation of a positive NTM sputum culture in the year following a positive urine LAM assay
- To determine the time between a positive LAM assay and a new positive NTM culture. [3 years]
Correlation of a positive NTM sputum culture up to 3 years following a positive urine LAM assay
- To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting. [3 years]
Excess urine will be used to develop and validate an alternative assay using ELISA.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent obtained online or in person from the participant
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Enrolled in the CFF Patient Registry (CFFPR)
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Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
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Able expectorate sputum and/or willing to undergo sputum induction (if necessary)
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Diagnosis of CF consistent with the 2017 CFF Guidelines
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NTM culture status of negative, as defined by a review of at least 3 year or more years of culture data and at least 3 NTM negative cultures with one of those negative cultures being within the last 3 years and no known history of previous positive cultures for pathogenic NTM by chart review.
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Jewish Health | Denver | Colorado | United States | 80206 |
Sponsors and Collaborators
- Jerry A. Nick, M.D.
Investigators
- Principal Investigator: Jerry A. Nick, MD, National Jewish Health
Study Documents (Full-Text)
None provided.More Information
Publications
- NICK20A0 20-08-402-528