Cystic Fibrosis (CF)SEND-CFNCT07312734
Study to Enable New Diagnostics for Pulmonary Microbes in People With CF
An observational study of Cystic Fibrosis (CF) and New Diagnostics, run by Chris Goss at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), New Diagnostics
- How many people
- 300 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Mar 2026to 1 Aug 2027
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites
Who may be able to join
- ≥ 16 years of age on day of study visit
- Documentation of CF Diagnosis
- Able to expectorate sputum
- Percent predicted FEV1 ≥ 30%
Who cannot join
- History of solid organ transplantation
- History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit
- Pregnant
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Diana Gilmore, Diana.Gilmore@nationwidechildrens.org
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Ashley Keller, Ashley.Keller@UTSouthwestern.edu
- Not yet recruiting
University of California San Diego
La Jolla, California, 92037
Jenna Mielke, 619-471-0822, jmielke@health.ucsd.edu
- Recruiting
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Erin Hubertz, ehubertz@mcw.edu
- Recruiting
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455
CF Trials Contact University of Minnesota, Participant Contact, cftrials@umn.edu
- Not yet recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 69198
Michel Veit, michel.veit@unmc.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Melissa Molter, melissa.molter@pennmedicine.upenn.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Adrienne DeRicco, adrienne.dericco2@upmc.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Irma Bauer, irmabauer@wustl.edu
About this study
Official title: Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)
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.
Read the 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.
- Conditions
- Cystic Fibrosis (CF), New Diagnostics
- Keywords
- Cystic Fibrosis, CF, Breath collection, Specimen collection, Detection of pathogens, New diagnostics
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start30 Mar 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris Goss
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, University of Pennsylvania
- Responsible party
- Sponsor-investigator, Chris Goss, Seattle Children's Hospital
- Investigators
- Gina Hong, MD, MHS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312734
- Sponsor's protocol ID
- SENDCF-OB-25
- Acronym
- SEND-CF
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)
- ClinicalTrials.gov ID
- NCT07312734
- Acronym / sponsor ID
- SEND-CF / SENDCF-OB-25
- Conditions
- Cystic Fibrosis (CF), New Diagnostics
- Keywords
- Cystic Fibrosis, CF, Breath collection, Specimen collection, Detection of pathogens, New diagnostics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chris GossUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, University of Pennsylvania
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 31 Dec 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites
Key inclusion criteria (4 listed)
- ≥ 16 years of age on day of study visit
- Documentation of CF Diagnosis
- Able to expectorate sputum
- Percent predicted FEV1 ≥ 30%
Key exclusion criteria (3 listed)
- History of solid organ transplantation
- History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
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 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis (CF)
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
Active, not recruitingObservational study
Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease
Cystic Fibrosis, Liver Disease
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
Recruiting
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
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.
Gina Hong, MD, MHS principal investigator
University of Pennsylvania
9 sites 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 (CF) and New Diagnostics, run by Chris Goss at 9 sites 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 3 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Contact Nikita Midamba (206-884-0599, Nikita.midamba@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.