PAN Cancer Early Detection
Research type
Research Study
Full title
PAN-study: Pan-Cancer Early Detection Study
IRAS ID
237560
Contact name
Marc P van der Schee
Contact email
Sponsor organisation
Owlstone Medical
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IRAS Project ID, 237560
Duration of Study in the UK
3 years, 10 months, 17 days
Research summary
The PAN Cancer Early Detection study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy (developed by Owlstone Medical Ltd.; the Sponsor of this study) can differentiate between patients with and without different cancer types, by comparing breath biomarkers of patients with gastric, oesophageal, pancreatic, renal, prostate and bladder cancer from matched controls. In total 82 cases (cancer) and 82 matched controls for each tumour type will be recruited at Cambridge University Hospitals NHS Foundation Trust, with an additional 164 healthy volunteers. Participants who consented to participation will be asked to provide 1 breath sample, using the ReCIVA breath collector (developed by Owlstone Medical Ltd. and CE-marked). For controls and cases,medical metadata (general medical history) will be collected as well as information on the diagnostic work-up and follow up data (general health data, details on therapy response for patients with confirmed cancer diagnosis, development of a malignancy during follow-up for matched controls) on the basis of the participant's medical charts. Follow-up data will be collected up to 12 months after the breath sample was collected. For healthy volunteers, clinical metadata and a telephone based follow up at 6 and 12 months will be collected. In a small subset of 15% of the participants, up to additional 4 breath samples will be collected to contribute to the development of a validated assay that can then be validated in further studies.
The anonymised breath samples will be analysed at the clinical laboratories of Owlstone Medical Ltd. in Cambridge. The study is a collaboration effort between Owlstone Medical Ltd., Cancer Research UK and University Cambridge Hospitals NHS Foundation.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0041
Date of REC Opinion
9 Apr 2018
REC opinion
Further Information Favourable Opinion