Transition From Pediatric to Adult Cystic Fibrosis Care Center

Cystic Fibrosis Clinical Trial

— SAFETIM RNM  

Official title:

Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02790879
• Other study ID #: 69HCL15_0629
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 3, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Hospices Civils de Lyon
• Contact: Stéphanie POUPON-BOURDY
• Phone: (0)4 72 11 54 16
• Email: stephanie.poupon-bourdy[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients.

This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis.

Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status.

Exclusion Criteria:

• Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Transition pediatric - adult

Locations

Country	Name	City	State
France	Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A	Lyon	Auvergne-Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FEV (FEV is the slope expressed in percentage of the predicted value).		Two years	No
Secondary	Body Mass Index (BMI)		Two years	No
Secondary	Pseudomonas aeruginosa colonization		Two years	No
Secondary	External pancreatic insufficiency		Two years	No
Secondary	Diabetes		Two years	No