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Clinical Trial 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.Íž 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.

Clinical Trial Description

There is a pressing need for techniques that allow detection of cancer at an earlier stage when curative treatment is more likely. Exhaled biomarkers are known to reflect a wide range of metabolic processes, including those related to cancer such as the Warburg effect. Owlstone Medical Ltd (hereafter referred to as Owlstone Medical) has developed Breath Biopsy; a workflow to collect and analyse breath Volatile Organic Compounds (VOCs) in a highly standardised way. The PAN-study is a collaborative effort between Cambridge University Hospitals NHS Foundation Trust (CUH), University of Cambridge (UoC), Cancer Research United Kingdom (CRUK) and Owlstone Medical to evaluate the potential of Breath Biopsy to detect various types of cancer by profiling breath metabolites.

The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by comparing breath biomarkers for a range of cancer types including patients with gastric, oesophageal, pancreatic, renal, prostate and bladder cancer. Subjects with a histologically confirmed cancer will be recruited from CUH by local research staff. Breath samples will be collected by means of the ReCIVA breath sampler which requires tidal breathing into a face mask for around 10 minutes. A cancer free control subject matched for age, sex and tumour specific risk factors will be recruited and sampled. Breath samples will be shipped to Owlstone Medical for analysis of breath biomarkers by Gas Chromatography-Time Of Flight-Mass Spectrometry (GC-TOF-MS) and Gas Chromatography-Field Asymmetric Ion Mobility Spectrometry (GC-FAIMS).

This study will be the first step towards evaluating VOCs analysis as a test to improve early detection rates for cancer with future applicability to primary care. Ultimately, such a research program could enable low cost and widespread targeted screening programs for cancer. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03756597
Study type Observational
Source Owlstone Ltd
Contact Georgina Karecla
Phone 01223 428200
Status Recruiting
Start date September 26, 2018
Completion date December 2021

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