Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

What this study is

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.

What's being tested

urine lipoarabinomannan (LAM)
Intervention · DIAGNOSTIC TEST
Investigate the utility of urine LAM as a test to identify individuals at very low risk for having a sputum culture positive for NTM.

Study details

Official title: Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
Sponsor: Jerry A. Nick, M.D.
Conditions: Cystic Fibrosis
Enrolling: 220 people
Starts: 2020-12-10
Est. completion: 2026-05-01
Record: View on ClinicalTrials.gov ↗

Who can join

Age 18 Years and overSex ALLHealthy volunteers Not accepted

You may qualify if

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)

You can't join if

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

Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗

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Study locations (1)

1 open

National Jewish Health
Denver, Colorado, United States

Study team

Sponsor

Jerry A. Nick, M.D.

Study ID NICK20A0 20-08-402-528

Principal investigator

Jerry A. Nick, MD

National Jewish Health

Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.

Frequently asked questions

The sponsor hasn't published answers to common questions for this trial.

A urine test (lipoarabinomannan) to screen for mycobacteria in adults with cystic fibrosis