MedTrace Logo

COlorectal BReath Analysis (COBRA2)

NCT05844514 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 720

Last updated 2025-06-13

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

Breath test

Patients must be fasted for a minimum of 4-6 hours prior to breath sample collection. For patients undergoing colonoscopy or surgery, breath samples must be obtained prior to patients receiving bowel preparation in either outpatient clinic or pre-assessment clinic.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Chelsea and Westminster NHS Foundation Trust

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • London North West Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Professor George B Hanna, PhD FRCS · Imperial College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2026-04-01
Completion
2026-12-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05844514 on ClinicalTrials.gov