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Enrolling by Invitation

NCT Number: NCT04579211

Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

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

Secondary outcomes

  1. 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

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

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

    Time frame: 3 years

    Correlation of a positive NTM sputum culture up to 3 years following a positive urine LAM assay

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

    Time frame: 3 years

    Excess urine will be used to develop and validate an alternative assay using ELISA.

Sponsors and collaborators

Lead sponsor

Jerry A. Nick, M.D.

Other

Registry information

Official study title

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

Acronym: PAINLESS

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2020
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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