MedTrace Logo

Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

NCT04579211 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2025-05-23

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Jerry A. Nick, M.D.

    lead OTHER

Principal Investigators

  • Jerry A. Nick, MD · National Jewish Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2025-04-01
Completion
2026-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579211 on ClinicalTrials.gov