Breath test for early detection of colorectal cancer
Official title: The COlorectal BReath Analysis (COBRA2) Study: Non-invasive Breath Testing to Detect Colorectal Cancer
Run by Imperial College London · NCT05844514 · Data updated 2026-11-12
This study is testing a breath test to see if it can help find colorectal cancer earlier in people who have symptoms or already know they have the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 720 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 5 sites (London and 4 other locations) |
| Status | Recruiting |
| Started | September 23, 2022 |
| Main results expected | April 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT05844514 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include symptomatic patients aged 18 and older referred for colonoscopy and those with histologically confirmed colorectal adenocarcinoma who are treatment naïve.
✕Probably not a fit
Patients who have had previous colorectal resections or those who have received prior treatment for CRC will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The COBRA2 study aims to validate and discover volatile organic compound (VOC) biomarkers specific to colorectal cancer (CRC) through a non-invasive breath analysis. This observational study will recruit symptomatic patients undergoing colonoscopy and those with confirmed CRC to assess the effectiveness of the breath test compared to traditional fecal immunochemical tests. By refining detection models and exploring the combination of tests, the study seeks to enhance early diagnosis of CRC, which is crucial for improving patient outcomes. The study will involve a multicenter approach with a target recruitment of 720 patients.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of colorectal cancer, potentially saving lives through timely treatment.
How similar studies have gone: Previous studies have shown promise in using breath analysis for cancer detection, but this specific approach is novel and aims to build on earlier findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 18 years referred from primary care with symptoms of suspected CRC. * Patients with histologically confirmed colorectal adenocarcinoma (stages I-IV) who are treatment naïve (CRC group). Exclusion Criteria - patients with any of the following will not be eligible for inclusion: * Previous surgery altering the anatomy of the lower GI tract (e.g., hemicolectomy, anterior resection). * Previous treatment (neoadjuvant chemotherapy or radiotherapy or immunotherapy) for CRC. * Received bowel preparation for their colonoscopy procedure. * History of any other cancer within three years. * Unable or unwilling to provide informed written consent.
Where it's running
-
Chelsea and Westminster Hospital
London, United Kingdom Recruiting -
St Mary's Hospital
London, United Kingdom Recruiting -
West Middlesex University Hospital
London, United Kingdom Recruiting -
Royal Marsden Hospital
London, United Kingdom Active not recruiting -
St Mark's Hospital
London, United Kingdom Active not recruiting
Study contacts
- Principal investigator: Professor George B Hanna, PhD FRCS — Imperial College London
- Study coordinator: Mr Michael G Fadel, BSc MBBS MRCS
- Email: m.fadel@imperial.ac.uk
- Phone: +44 (0)20 7594 3396
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.