Cystic Fibrosis (CF), New Diagnostics
Conditions
Keywords
Cystic Fibrosis, CF, Breath collection, Specimen collection, Detection of pathogens, New diagnostics
Brief summary
Sputum culture has been the best approach to detect harmful bacteria in the lungs of people with cystic fibrosis (CF). With the widespread use of new CF therapies (like Trikafta and Alyftrak), it is more difficult for people with CF to produce sputum even though they still have harmful bacteria in their lungs. The SEND-CF study is being done to see if there are other ways to detect harmful bacteria in the lungs.
Detailed description
People with cystic fibrosis (CF) often get lung infections that can make their breathing worse and make their lungs weaker over time. Sputum culture is usually analyzed to find these infections. Currently, many people with CF are using CFTR modulators. These medicines help, but they also make it harder for people to cough up sputum. Even though people with CF are making less sputum, lung infections are still a problem. New ways are needed to check for infections without using sputum. The SEND-CF study wants to gather health information and samples from people with CF in order to find new and better ways to spot harmful bacteria in the lungs. Participants, who typically are able to produce sputum who consent to participate will be asked to provide samples including sputum, saliva, serum, plasma, buffy coat, urine, and whole blood. Some participants will also provide breath samples for a sub-study.
Interventions
None listed
Sponsors
Chris Goss
Cystic Fibrosis Foundation
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 16 years of age on day of study visit * Documentation of CF Diagnosis * Able to expectorate sputum * Percent predicted FEV1 ≥ 30%
Exclusion criteria
* History of solid organ transplantation * History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate alternative methods for the detection of microbial pathogens from the lungs of people with CF by comparing against the gold standard of sputum cultures. | Baseline Visit | Specimens (including sputum, saliva, blood, urine, and breath (for the Owlstone Device Sub-Study)) will be collected at the Study Visit. These specimens will be stored at a biorepository and be made available to the research community to test and validate diagnostic assays for the detection of CF pathogens. |
Countries
United States
Contacts
CONTACTNikita Midamba
CONTACTAnna Mead
PRINCIPAL_INVESTIGATORGina Hong, MD, MHS
University of Pennsylvania
Outcome results
None listed