Transition From Pediatric to Adult Cystic Fibrosis Care Center

• Conditions: Cystic Fibrosis
• Interventions: Other: Transition pediatric - adult

• Registration Number: NCT02790879
• Lead Sponsor: Hospices Civils de Lyon

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-05
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-03
• Last Update Submitted: 2016-06-03
• Study First Posted: 2016-06-06
• Last Update Posted: 2016-06-06
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transition	Transition pediatric - adult	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.

Primary Outcome Measures

Name	Time	Method
Changes in FEV (FEV is the slope expressed in percentage of the predicted value).	Two years

Secondary Outcome Measures

Name	Time	Method
Pseudomonas aeruginosa colonization	Two years
Body Mass Index (BMI)	Two years
External pancreatic insufficiency	Two years
Diabetes	Two years

Trial Locations

Locations (1)

Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A; 🇫🇷 Lyon, Auvergne-Rhône-Alpes, France