CF-STAR
Research type
Research Study
Full title
CF-STAR: Cystic Fibrosis ReSearch DaTA MeRge
IRAS ID
302211
Contact name
Andres Floto
Contact email
Sponsor organisation
Royal Papworth Hospital NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is a three-year, observational, retrospective cohort study. We aim to systematically merge data from the following cystic fibrosis (CF) research studies:
1) SmartCare Study
a. REC / 14/EE/1244 – IRAS 163484
b. 147 patients recruited from 7 UK centres
2) Project Breathe Study
a. REC / 18/NI/0215 – IRAS 250936
b. 610 patients recruited from 4 centres
and link anonymously to detailed longitudinal clinical metadata currently collected through the UK CF Patient Registry (REC/07/QO104/2) (funded by the CF Trust). This acts as a high-quality consented repository for detailed clinical metadata for almost all (99%) of the 10,500 individuals with CF in the UK.This would allow us to merge linked anonymised data from approximately 735 patients (as some patients have participated in both SmartCare and Project Breathe) within the UK, Scotland and Wales with the national UK CF Patient Registry.
Virtually all CF patients attend Specialist CF Centres (58 sited in 32 locations in the UK) that are mandated to upload annual detailed clinical metadata on each CF patient (including information about lung function, exacerbation frequency, CF complications, microbiology and medications). The Registry now contains 10 years of longitudinal data that is quality-assured and widely trusted, currently being used by the European Medicines Agency for pharmaco-vigilance and the by the NHS for resource allocation and policy development.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/PR/0884
Date of REC Opinion
28 Jun 2021
REC opinion
Favourable Opinion