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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579211
Recruitment Status : Enrolling by invitation
First Posted : October 8, 2020
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Jerry A. Nick, M.D., National Jewish Health

Study Description
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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.

Condition or disease Intervention/treatment
Cystic Fibrosis Diagnostic Test: urine lipoarabinomannan (LAM)

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
Investigate the utility of urine LAM as a test to identify individuals at very low risk for having a sputum culture positive for NTM.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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:

1. 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579211


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
Jerry A. Nick, M.D.
Investigators
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Principal Investigator: Jerry A. Nick, MD National Jewish Health
More Information
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Publications:

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Responsible Party: Jerry A. Nick, M.D., Director, Adult CF Program at National Jewish Health, National Jewish Health
ClinicalTrials.gov Identifier: NCT04579211    
Other Study ID Numbers: NICK20A0 20-08-402-528
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases