Transition From Pediatric to Adult Cystic Fibrosis Care C... | NCT02790879

Studies
Transition From Pediatric to Adult Cystic Fibrosis Care Center

NCT02790879

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Jun 6, 2016Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

Transition pediatric - adult

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

May 31, 2016

First Submission Date that Met QC Criteria

Jun 3, 2016

First Posted Date

Jun 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2016

Last Update Posted Date

Jun 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transition pediatric - adult	Other		Transition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in FEV (FEV is the slope expressed in percentage of the predicted value).		Two years

Secondary Outcomes

Measure	Description	Time Frame
Body Mass Index (BMI)		Two years
Pseudomonas aeruginosa colonization		Two years
External pancreatic insufficiency

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stéphanie POUPON-BOURDY	Contact	(0)4 72 11 54 16	+33	stephanie.poupon-bourdy@chu-lyon.fr
Sandrine TOUZET, MD	Contact	(0)4 72 11 51 62	+33	sandrine.touzet@chu-lyon.fr

Overall Officials

Name	Affiliation	Role
Sandrine TOUZET, MD	Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A	Recruiting	Lyon	Auvergne-Rhône-Alpes	69424	France

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D060305	Transition to Adult Care

Ancestor Terms

ID	Term
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided