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ENROLLING BY INVITATION
NCT04579211

Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

Sponsor: Jerry A. Nick, M.D.

View on ClinicalTrials.gov

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.

Official title: Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2020-12-10

Completion Date

2026-05-01

Last Updated

2025-05-23

Healthy Volunteers

No

Conditions

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.

Locations (1)

National Jewish Health

Denver, Colorado, United States