NCT06599892 CF Organization of Care in the Era of Highly Effective Modulator.
| NCT ID | NCT06599892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 5,000 participants in total. It began in 2023-09-01 with a primary completion date of 2026-12-31.
⚠ 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
Recently, triple therapy has made it possible to extend access to these modulators to a large proportion of the patient population, with spectacular clinical benefits, provided the patient carries at least one F508del mutation. The hypothesis is that the arrival of CFTRmHEs has considerably altered the way cystic fibrosis is managed, requiring a rethink of how the CRCMs are organised, and a redefinition of the practices and missions of professionals, as well as the patient-professional relationship.
Eligibility Criteria
Inclusion Criteria: * Patients aged 6 and over with cystic fibrosis treated with CFTRmHE for at least 12 months * Patients aged over 6 years with cystic fibrosis not eligible for CFTRmHE treatment * Families of patients under 18 years of age * Professionals working in a CRCM for more than 12 months, physiotherapists and community nurses involved in the management of cystic fibrosis. Exclusion Criteria \* : * Refusal to participate * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Adults under legal protection (guardianship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Contact & Investigator
Philippe REIX, Professor
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT06599892 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, 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 NCT06599892 currently recruiting?
Yes, NCT06599892 is actively recruiting participants. Contact the research team at philippe.reix@chu-lyon.fr for enrollment information.
Where is the NCT06599892 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06599892 clinical trial?
NCT06599892 is sponsored by Hospices Civils de Lyon. The principal investigator is Philippe REIX, Professor at Hospices Civils de Lyon. The trial plans to enroll 5,000 participants.