Transition From Pediatric to Adult Cystic Fibrosis Care Center (SAFETIM RNM)
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|ClinicalTrials.gov Identifier: NCT02790879|
Recruitment Status : Unknown
Verified May 2016 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
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).
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis||Other: Transition pediatric - adult|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
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.
Other: Transition pediatric - adult
- Changes in FEV (FEV is the slope expressed in percentage of the predicted value). [ Time Frame: Two years ]
- Body Mass Index (BMI) [ Time Frame: Two years ]
- Pseudomonas aeruginosa colonization [ Time Frame: Two years ]
- External pancreatic insufficiency [ Time Frame: Two years ]
- Diabetes [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790879
|Contact: Stéphanie POUPON-BOURDY||(0)4 72 11 54 16 ext +email@example.com|
|Contact: Sandrine TOUZET, MD||(0)4 72 11 51 62 ext +firstname.lastname@example.org|
|Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A||Recruiting|
|Lyon, Auvergne-Rhône-Alpes, France, 69424|
|Contact: Sandrine TOUZET, MD (0)4 72 11 51 62 ext +33 email@example.com|
|Principal Investigator:||Sandrine TOUZET, MD||Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche|