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Clinical Trials/NCT02790879
NCT02790879UnknownNot Applicable

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

Hospices Civils de Lyon1 site in 1 country300 target enrollmentStarted: October 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Changes in FEV (FEV is the slope expressed in percentage of the predicted value).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Changes in FEV (FEV is the slope expressed in percentage of the predicted value).

Time Frame: Two years

Secondary Outcomes

  • Body Mass Index (BMI)(Two years)
  • Pseudomonas aeruginosa colonization(Two years)
  • External pancreatic insufficiency(Two years)
  • Diabetes(Two years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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