Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: urine lipoarabinomannan (LAM).
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
Overview
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.
Interventions
- 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.
Primary outcome measures
- To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months. [Time frame: From time enrollment to over the next 12 months]
Secondary outcome measures (3)
- To determine the ability of the urine LAM assay to predict new positive NTM sputum culture over the next 12 months. [Time frame: 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. [Time frame: 3 years]
- To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting. [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
1\. 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- National Jewish Health — Denver
Publications
- De P, Amin AG, Graham B, Martiniano SL, Caceres SM, Poch KR, Jones MC, Saavedra MT, Malcolm KC, Nick JA, Chatterjee D. Urine lipoarabinomannan as a marker for low-risk of NTM infection in the CF airway. J Cyst Fibros. 2020 Sep;19(5):801-807. doi: 10.1016/j.jcf.2020.06.016. Epub 2020 Jul 3. PMID 32624408
Identifiers
NCT: NCT04579211 · NICK20A0 20-08-402-528