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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| Children's Hospital Colorado | OTHER |
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Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF patients | Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion meeting the diagnosis of NTM disease | 12 months intervals following study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol | 12 months intervals following study enrollment | |
| Incidence and prevalence of NTM species/subspecies by geographical region |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.
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| Name | Affiliation | Role |
|---|---|---|
| Jerry A Nick, MD | National Jewish Health | Principal Investigator |
| Stacey Martiniano, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CFF Pediatric Program, University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital of Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37666709 | Derived | Martiniano SL, Caceres SM, Poch K, Rysavy NM, Lovell VK, Armantrout E, Jones M, Anthony M, Keck A, Nichols DP, Vandalfsen JM, Sagel SD, Wagner B, Xie J, Weaver K, Heltshe SL, Daley CL, Davidson RM, Nick JA; Investigators of the Cystic Fibrosis NTM Consortium. Prospective evaluation of nontuberculous mycobacteria disease in cystic fibrosis: The design of the PREDICT study. J Cyst Fibros. 2024 Jan;23(1):50-57. doi: 10.1016/j.jcf.2023.08.007. Epub 2023 Sep 4. |
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Samples collected may include serum, sputum, whole blood, breath, urine, and NTM isolates.
| 12 months intervals following study enrollment |
| Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site | 12 months intervals following study enrollment |
| Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE | 12 months intervals following study enrollment |
| Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R) | 12 months intervals following study enrollment |
| Los Angeles |
| California |
| United States |
| University of California San Diego | San Diego | California | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| University of Florida | Gainesville | Florida | United States |
| Northwestern University | Chicago | Illinois | United States |
| CFF Adult Program, Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Boston Children's Hospital, Brigham & Women's Hospital | Boston | Massachusetts | United States |
| CFF Pediatric Program University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States |
| CFF Pediatric Program, Columbia University | New York | New York | 10032 | United States |
| CFF Adult Program, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390-8558 | United States |
| University of Vermont Medical Center | Burlington | Vermont | United States |
| CFF Pediatric Program Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| CFF Adult Program, University of Washington | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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