Recruiting

Observational Study

Sponsor:

Chris Goss

Code:

NCT07312734

Conditions

Cystic Fibrosis (CF)

New Diagnostics

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cystic Fibrosis (CF)

New Diagnostics

Study ID

NCT07312734

Start date

Mar 30, 2026

Status verified date

Jun, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Central contacts

Nikita Midamba

206-884-0599Nikita.midamba@seattlechildrens.org

Anna Mead

206-884-7531Anna.mead@seattlechildrens.org

Locations

The Minnesota Cystic Fibrosis Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

CF Trials Contact University of Minnesota, Participant Contact

cftrials@umn.edu

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Irma Bauer

irmabauer@wustl.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Melissa Molter

melissa.molter@pennmedicine.upenn.edu

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Adrienne DeRicco

adrienne.dericco2@upmc.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Ashley Keller

Ashley.Keller@UTSouthwestern.edu

Froedtert & Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Erin Hubertz

ehubertz@mcw.edu

More Information

Sponsor

Chris Goss

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Cystic Fibrosis
  • CF
  • Breath collection
  • Specimen collection
  • Detection of pathogens
  • New diagnostics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Chris Goss on 2026-07-02.