Cystic FibrosisSAFETIM RNMNCT02790879
Transition From Pediatric to Adult Cystic Fibrosis Care Center
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Transition pediatric - adult
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A
Lyon, Auvergne-Rhône-Alpes, 69424
Sandrine TOUZET, MD, (0)4 72 11 51 62 ext. +33, sandrine.touzet@chu-lyon.fr
About this study
Official title: Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center
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).
- Conditions
- Cystic Fibrosis
- Being tested
- Transition pediatric - adult
- Keywords
- Transitional care, teenagers, cystic fibrosis, pulmonary function, nutritional function, Patients who experiment a transition pediatric - adult care
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition pediatric - adultOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transition pediatric - adult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FEV (FEV is the slope expressed in percentage of the predicted value).
Measured: Two years
Secondary outcomes (4)
Body Mass Index (BMI)
Measured: Two years
Pseudomonas aeruginosa colonization
Measured: Two years
External pancreatic insufficiency
Measured: Two years
Diabetes
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine TOUZET, MD, Principal investigator, Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790879
- Sponsor's protocol ID
- 69HCL15_0629
- Acronym
- SAFETIM RNM
- Status last verified
- May 2016
- First submitted
- 31 May 2016
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center
- ClinicalTrials.gov ID
- NCT02790879
- Acronym / sponsor ID
- SAFETIM RNM / 69HCL15_0629
- Conditions
- Cystic Fibrosis
- Keywords
- Transitional care, teenagers, cystic fibrosis, pulmonary function, nutritional function, Patients who experiment a transition pediatric - adult care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transition | – | Other: Transition pediatric - adultPatients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition pediatric - adult | Other | Transition |
Primary outcome
Changes in FEV (FEV is the slope expressed in percentage of the predicted value).
Time frame: Two years
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine TOUZET, MD principal investigator
Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie POUPON-BOURDY ((0)4 72 11 54 16 ext. +33, stephanie.poupon-bourdy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FEV (FEV is the slope expressed in percentage of the predicted value). (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.