The CF-Tracker study
Research type
Research Study
Full title
The CF-Tracker study: identifying the causes and risk factors of pulmonary exacerbations in cystic fibrosis
IRAS ID
338539
Contact name
Alex Horsley
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The CF-Tracker study is a community surveillance study, designed to understand the causes of exacerbations in people with cystic fibrosis (CF) (pwCF). These are episodes when pwCF become more unwell, typically characterised by increased cough, sputum, and breathlessness, and requiring prolonged courses of oral or intravenous antibiotics.
This observational study applies a two-tiered approach over 12 months. It will recruit 200 pwCF to Group A, and an additional 100 pwCF to Group B, which follows the same format but includes additional in-clinic sampling. Participants will provide longitudinal clinical data and biological samples. Group B will be offered at 4 specialist CF centres (Manchester, Cardiff, Newcastle, Leeds), will include additional sampling methods at clinic visits, and additional scheduled clinic visits at 1 month and 6 months. Group B participants will be offered an in-person visit if they become unwell, so that samples can be collected before they start antibiotics. In Group B, those attending the Manchester clinic will have the option of taking part in a 12 month home environmental and pollution monitoring, and sleep monitoring (both optional arms).
A pilot study will test the practicalities of running the same protocol in a paediatric population. This will consist of up to 25 children with CF (5-15 years) attending a paediatric clinic in one of the four core centres. Up to 40 healthy volunteers will be recruited to provide samples on a single occasion as controls.
This study is funded by the Cystic Fibrosis Trust. This study is part of a wider programme of research, led by the PULSE-CF Innovation Hub (and hosted by the University of Manchester). The aim of the Hub is that the data from Tracker will support the delivery of a platform clinical trial to test exacerbation-prevention interventions in CF.
REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0271
Date of REC Opinion
24 Dec 2024
REC opinion
Further Information Favourable Opinion