Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

NCT04579211 | Enrolling By Invitation

• 1 other identifier: NICK20A0 20-08-402-528
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months.

  Correlation of a negative NTM sputum culture in the year following a negative urine LAM assay

  From time enrollment to over the next 12 months

Secondary Outcomes (3)

• 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

• To determine the time between a positive LAM assay and a new positive NTM culture.

  3 years

• To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting.

  3 years

Study Arms (1)

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)

Interventions

urine lipoarabinomannan (LAM) 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.

Adults with a diagnosis of CF with history of negative NTM sputum cultures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 adult male or female participants with a diagnosis of CF and NTM culture status of negative and no known previous positive cultures for pathogenetic NTM

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 may not qualify 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

Sponsors & Collaborators

• Jerry A. Nick, M.D.: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jerry A. Nick, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Adult CF Program at National Jewish Health

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: December 10, 2020
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

US (1)