NCT04579211Enrolling by invitation
Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening
Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS Trial)
Source: ClinicalTrials.gov · Last updated 23 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 1 Oct 2020
- Start date
- 10 Dec 2020
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Jerry A. Nick, M.D.
- Diseases
- Cystic fibrosis
- NCT number
- NCT04579211
What you commit to
- Study type: Observational
- Planned participants: 220
- From 10 Dec 2020 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.