COlorectal BReath Analysis (COBRA2)
The COlorectal BReath Analysis (COBRA2) Study: Non-invasive Breath Testing to Detect Colorectal Cancer
1 other identifier
observational
720
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2022
CompletedFirst Submitted
Initial submission to the registry
April 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJune 13, 2025
June 1, 2025
3.5 years
April 25, 2023
June 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validation and further discovery of VOC biomarkers for CRC.
GC-MS will be used to confirm the presence of certain CRC-associated VOCs in order to develop the detection model.
24 months
Secondary Outcomes (1)
Exploratory comparison between the breath test and FIT.
24 months
Study Arms (2)
Control group - 470 patients
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.
CRC group - 250 patients
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).
Interventions
Patients must be fasted for a minimum of 4-6 hours prior to breath sample collection. For patients undergoing colonoscopy or surgery, breath samples must be obtained prior to patients receiving bowel preparation in either outpatient clinic or pre-assessment clinic.
Eligibility Criteria
Patients seen in a hospital (secondary or tertiary level care) setting
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- National Institute for Health Research, United Kingdomcollaborator
- Chelsea and Westminster NHS Foundation Trustcollaborator
- Imperial College Healthcare NHS Trustcollaborator
- Royal Marsden NHS Foundation Trustcollaborator
- London North West Healthcare NHS Trustcollaborator
Study Sites (5)
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
Related Publications (1)
Fadel 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: 40731329DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor George B Hanna, PhD FRCS
Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2023
First Posted
May 6, 2023
Study Start
September 23, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share