Cystic FibrosisPAINLESSNCT04579211
Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening
An observational study of Cystic Fibrosis, run by Jerry A. Nick, M.D. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- urine lipoarabinomannan (LAM)
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
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
- Being tested
- urine lipoarabinomannan (LAM)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: urine lipoarabinomannan (LAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Correlation of a positive NTM sputum culture in the year following a positive urine LAM assay
Measured: 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.
Correlation of a positive NTM sputum culture up to 3 years following a positive urine LAM assay
Measured: 3 years
To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting.
Excess urine will be used to develop and validate an alternative assay using ELISA.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start10 Dec 2020
- Primary completion1 Apr 2025
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerry A. Nick, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jerry A. Nick, M.D., National Jewish Health
- Investigators
- Jerry A. Nick, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579211
- Sponsor's protocol ID
- NICK20A0 20-08-402-528
- Acronym
- PAINLESS
- Status last verified
- May 2025
- First submitted
- 1 Oct 2020
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32624408Calhoun KM, Armantrout E, Poch K, Caceres S, Lovell VK, Jones M, Malcolm KC, Vestal B, Wheeler E, Rysavy N, Manzer J, Aboellail I, Chatterjee D, Nick JA. Prospective Analysis of urINe LAM to Eliminate NTM Sputum Screening (PAINLESS) study: Rationale and trial design for testing urine lipoarabinomannan as a marker of NTM lung infection in cystic fibrosis. PLoS One. 2025 Mar 10;20(3):e0309191. doi: 10.1371/journal.pone.0309191. eCollection 2025.
PubMed 40063876
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
- ClinicalTrials.gov ID
- NCT04579211
- Acronym / sponsor ID
- PAINLESS / NICK20A0 20-08-402-528
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jerry A. Nick, M.D.University, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with a diagnosis of CF with history of negative NTM sputum cultures | – | Diagnostic Test: urine lipoarabinomannan (LAM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Adults with a diagnosis of CF with history of negative NTM sputum cultures |
Primary outcome
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
3 secondary outcomes
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
To determine the time between a positive LAM assay and a new positive NTM culture.
Time frame: 3 years
To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 32624408De 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.
- Derived from this study: PubMed 40063876Calhoun KM, Armantrout E, Poch K, Caceres S, Lovell VK, Jones M, Malcolm KC, Vestal B, Wheeler E, Rysavy N, Manzer J, Aboellail I, Chatterjee D, Nick JA. Prospective Analysis of urINe LAM to Eliminate NTM Sputum Screening (PAINLESS) study: Rationale and trial design for testing urine lipoarabinomannan as a marker of NTM lung infection in cystic fibrosis. PLoS One. 2025 Mar 10;20(3):e0309191. doi: 10.1371/journal.pone.0309191. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerry A. Nick, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Jerry A. Nick, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579211, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.