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NCT06599892Recruiting

CF Organization of Care in the Era of Highly Effective Modulator.

Rethinking CF Organization of Care in the Era of Highly Effective Modulator: a Nationwide Research Program HORIZON.

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
12 Aug 2024
Start date
1 Sept 2023
Primary completion date
31 Dec 2026
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT06599892

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 1 Sept 2023 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Persons under psychiatric care

Other

  • Refusal to participate
  • Persons deprived of their liberty by judicial or administrative decision
  • Adults under legal protection (guardianship, curatorship)
  • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Who the study is looking for

  • 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.

Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Groupement Hospitalier Est Pediatric CFcenter
Coordinator of this site? Confirm its status
LyonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.