NCT04793867 Regional Phenotyping of CF and Non-CF Bronchiectasis
| NCT ID | NCT04793867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-02-08 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-02-08 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Investigators propose to study pediatric subjects who are diagnosed with cystic fibrosis (CF) and patients with non-CF bronchiectasis, with the goal of developing markers of CF lung disease severity, progression, and therapy response. The Investigator's central hypothesis is that image-based markers can forecast pathophysiology prior to spirometric changes.
Eligibility Criteria
Inclusion Criteria: * CF Patients: Diagnosis of CF based on sweat chloride \>60 mMol/l * Presence of two disease causing CFTR mutations, or end organ manifestations of disease. * Age minimum 5 years. * Care provided by the CCHMC CF Care Center or other regional CF Care Centers if required to achieve recruitment goals. Exclusion Criteria: * Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.) * Pregnancy or lactation. Inclusion Criteria of Healthy Subjects: * Subjects 5 years of age and older with no known history of cardiopulmonary disease. Exclusion Criteria of Healthy Subjects: * Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.) * Pregnancy or lactation.
Contact & Investigator
Zackary I Cleveland, PhD
PRINCIPAL INVESTIGATOR
CCHMC
Frequently Asked Questions
Who can join the NCT04793867 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 100 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04793867 currently recruiting?
Yes, NCT04793867 is actively recruiting participants. Contact the research team at penny.new@cchmc.org for enrollment information.
Where is the NCT04793867 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04793867 clinical trial?
NCT04793867 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Zackary I Cleveland, PhD at CCHMC. The trial plans to enroll 100 participants.