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NCT05844514Recruiting

COlorectal BReath Analysis (COBRA2)

The COlorectal BReath Analysis (COBRA2) Study: Non-invasive Breath Testing to Detect Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
720 (estimated)
First submitted
25 Apr 2023
Start date
23 Sept 2022
Primary completion date
1 Apr 2026
Lead sponsor
Imperial College London
NCT number
NCT05844514

What you commit to

  • Study type: Observational
  • Planned participants: 720
  • From 23 Sept 2022 to the primary completion date, 1 Apr 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • History of any other cancer within three years.

Other

  • Unable or unwilling to provide informed written consent.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Mark's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomActive, not recruiting
West Middlesex University Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Chelsea And Westminster Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Royal Marsden Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomActive, not recruiting
St Mary's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.