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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
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Cystic Fibrosis Other: Transition pediatric - adult

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Transition
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



Primary Outcome Measures :
  1. Changes in FEV (FEV is the slope expressed in percentage of the predicted value). [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Two years ]
  2. Pseudomonas aeruginosa colonization [ Time Frame: Two years ]
  3. External pancreatic insufficiency [ Time Frame: Two years ]
  4. Diabetes [ Time Frame: Two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Stéphanie POUPON-BOURDY (0)4 72 11 54 16 ext +33 stephanie.poupon-bourdy@chu-lyon.fr
Contact: Sandrine TOUZET, MD (0)4 72 11 51 62 ext +33 sandrine.touzet@chu-lyon.fr

Locations
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France
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    sandrine.touzet@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sandrine TOUZET, MD Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche

Additional Information:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02790879     History of Changes
Other Study ID Numbers: 69HCL15_0629
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: May 2016
Keywords provided by Hospices Civils de Lyon:
Transitional care
teenagers
cystic fibrosis
pulmonary function
nutritional function
Patients who experiment a transition pediatric - adult care
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases