Breath test for early detection of colorectal cancer
The COlorectal BReath Analysis (COBRA2) Study: Non-invasive Breath Testing to Detect Colorectal Cancer
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 |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 5 sites (London and 4 other locations) |
| Trial ID | NCT05844514 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London and 4 other locations
- Chelsea and Westminster Hospital — London, United Kingdom (Recruiting)
- Royal Marsden Hospital — London, United Kingdom (Active_not_recruiting)
- St Mark's Hospital — London, United Kingdom (Active_not_recruiting)
- St Mary's Hospital — London, United Kingdom (Recruiting)
- West Middlesex University Hospital — London, United Kingdom (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.