Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05844514

COlorectal BReath Analysis (COBRA2)

Led by Imperial College London · Updated on 2025-06-13

720

Participants Needed

5

Research Sites

218 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

N

National Institute for Health Research, United Kingdom

Collaborating Sponsor

AI-Summary

What this Trial Is About

Colorectal cancer (CRC) is the second most common cause of cancer death in the United Kingdom, with approximately 17,000 deaths per year. The five-year survival rate from CRC is only 10% when discovered at a late stage, but exceeds 90% if diagnosed early. Symptoms related to CRC can be non-specific, therefore the decision to refer for a colonoscopy can be challenging. There is a clear need to improve earlier detection of CRC so that patients with CRC can be identified earlier and faster, enabling them to start treatment more quickly. The study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that are specific to CRC. For patients with non-specific symptoms, this test would help GPs to identify those patients that may have underlying CRC, who would benefit from referral for specialised CRC tests.

CONDITIONS

Official Title

COlorectal BReath Analysis (COBRA2)

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 2518 years or older referred from primary care with symptoms of suspected colorectal cancer.
  • Patients with histologically confirmed colorectal adenocarcinoma (stages I-IV) who have not yet received treatment.
Not Eligible

You will not qualify if you...

  • Previous surgery altering the anatomy of the lower gastrointestinal tract, such as hemicolectomy or anterior resection.
  • Previous treatment with chemotherapy, radiotherapy, or immunotherapy for colorectal cancer.
  • Received bowel preparation for their colonoscopy procedure.
  • History of any other cancer within the last three years.
  • Unable or unwilling to provide informed written consent.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Chelsea and Westminster Hospital

London, United Kingdom

Actively Recruiting

2

Royal Marsden Hospital

London, United Kingdom

Active, Not Recruiting

3

St Mark's Hospital

London, United Kingdom

Active, Not Recruiting

4

St Mary's Hospital

London, United Kingdom

Actively Recruiting

5

West Middlesex University Hospital

London, United Kingdom

Actively Recruiting

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Research Team

M

Mr Michael G Fadel, BSc MBBS MRCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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COlorectal BReath Analysis (COBRA2) | DecenTrialz