COlorectal BReath Analysis (COBRA2)
Recruiting · NCT05844514 · Observational (researchers observe without assigning treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
5 locations listed.
- Chelsea and Westminster Hospital - London, United Kingdom
- Royal Marsden Hospital - London, United Kingdom
- St Mark's Hospital - London, United Kingdom
- St Mary's Hospital - London, United Kingdom
- West Middlesex University Hospital - London, United Kingdom