PAN-study: Pan-Cancer Early Detection Study (PAN)

NCT03756597 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 268

Last updated 2023-10-05

No results posted yet for this study

Summary

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, and liver cancer.

The research may be extended to include also pancreatic, renal, prostate and bladder cancer patients, however in agreement between Cambridge University Hospital NHS Foundation Trust, University of Cambridge, CRUK and Owlstone Medical recruitment in these arms will not start until further notice. When recruitment is planned to start in these arms, Owlstone Medical will ensure to notify the REC. 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.

Conditions

Interventions

DEVICE

ReCIVA

The ReCIVA breath sampler contains a CO2 and pressure sensor, which allows the operator to monitor the breath sampling procedure and patient comfort. Both the operator and the patient can pause or abort the breath sampling procedure within seconds by removing the mask. The time investment required from patients is approximately 15 minutes for consenting and medical history and 10 minutes per breath collection.

DEVICE

CASPER

Minimizes contamination of breath samples by external VOCs Removes need for clean air supply line

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER
  • Cancer Research UK

    collaborator OTHER
  • Owlstone Ltd

    lead INDUSTRY

Principal Investigators

  • Marc P van der Schee, MD, PhD · +01223 428200

  • Prof Rebecca Fitzgerald, MD, PhD · Cambridge University Hospital

  • Massimiliano di Pietro, MD, PhD · Cambridge University Hospital

  • Mr Vincent J Gnanapragasam, MD, PhD · Cambridge University Hospital

  • Mr Grant Stewart, MD, PhD · Cambridge University Hospital

  • Dr Godfrey Edmund, MD, PhD · Cambridge University Hospital

  • Miss Alexandra Colquhoun, · Cambridge University Hospital

  • Dr Victoria Snowdon · Cambridge University Hospital

  • Dr Matthew Hoare · Cambridge University Hospital

  • Dr Michael Allison · Cambridge University Hospital

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2022-12-02
Completion
2023-07-06

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756597 on ClinicalTrials.gov