Clinical trial · Observational
COlorectal BReath Analysis (COBRA2)
The COlorectal BReath Analysis (COBRA2) Study: Non-invasive Breath Testing to Detect Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group - 470 patients
- description
- Symptomatic patients who are attending a planned colonoscopy referred under the suspected lower GI cancer pathway. Any patient who is found to have histologically-proven CRC on colonoscopy will be analysed as part of the CRC group.
- interventionNames
- Diagnostic Test: Breath test
- label
- CRC group - 250 patients
- description
- Patients who either have a confirmed diagnosis of colorectal adenocarcinoma according to a biopsy, or who are due to undergo surgical resection for suspected CRC (with histological confirmation to follow within three months).
- interventionNames
- Diagnostic Test: Breath test
Primary outcomes (1)
- measure
- Validation and further discovery of VOC biomarkers for CRC.
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFadel MG, Murray J, Woodfield G, Belluomo I, Laponogov I, Parker A, Converso V, Ellis JK, Wheatstone P, Hepburn J, Groves C, Monahan K, Saunders BP, Spanel P, Veselkov K, Cross AJ, Kontovounisios C, Sharples LD, Hanna GB; COBRA2 Collaborators. Non-invasive breath testing to detect colorectal cancer: protocol for a multicentre, case-control development and validation study (COBRA2 study). BMC Cancer. 2025 Jul 29;25(1):1230. doi: 10.1186/s12885-025-14520-2. PMID 40731329