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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
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
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jerry A. Nick, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32624408 | Background | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Urine
Correlation of a positive NTM sputum culture up to 3 years following a positive urine LAM assay |
| 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. | 3 years |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |