The Colorectal Breath Analysis (COBRA) Study
COBRA
Non-invasive Testing for the Diagnosis and Assessment of Colorectal Disease
1 other identifier
observational
1,855
1 country
8
Brief Summary
This study aims to determine whether a breath test could be used for early detection of colorectal cancer and colorectal polyps. Patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal cancer (adenocarcinoma) will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between colorectal cancer, benign colorectal disease (e.g. polyps) and healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
8 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
June 3, 2017
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedResults Posted
Study results publicly available
November 21, 2024
CompletedNovember 21, 2024
September 1, 2024
3.1 years
October 3, 2018
March 27, 2023
September 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the Diagnostic Accuracy of the Proposed Breath Test for Detection of Colorectal Cancer in All Patients
Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of colorectal cancer, as diagnosed on colonoscopy, using 14 specific VOCs plus BMI as prediction variables.
30 minutes
Determine the Diagnostic Accuracy of Using VOCs Present in Breath for the Detection of Colorectal Cancer in Symptomatic Patients
Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of colorectal cancer, as diagnosed on colonoscopy, using 14 specific VOCs plus BMI as prediction variables.
30 minutes
Study Arms (2)
Non cancer control patients
Patients who are attending hospital for a colonoscopy as part of their routine clinical care, or as part of the Bowel Cancer Screening Programme, will be asked to give a sample of their breath prior to the procedure. Those without a finding of colorectal adenocarcinoma will go into this group.
Colorectal cancer patients
Patients who have known pre-diagnosed colorectal cancer (adenocarcinoma) attending hospital as part of their clinical care will be asked to give a breath sample prior to their cancer operation. Patients who are attending hospital for a colonoscopy as part of their routine clinical care, or as part of the Bowel Cancer Screening Programme, will be asked to give a sample of their breath prior to the procedure. Those with a finding of colorectal adenocarcinoma will go into this group.
Interventions
Patients will be asked to give a sample of their breath, using the ReCIVA breath testing device. This involves performing tidal breathing whilst wearing a face mask for approximately 5 minutes. Breath (500mls at a flow rate of 200mls/min) is passed over thermal desorption tubes which absorb compounds of interest.
Eligibility Criteria
Patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal adenocarcinoma will be eligible for inclusion in this study
You may qualify if:
- ≥18 years and ≤90 years of age
- Undergoing planned colonoscopy or elective resection of histologically confirmed colorectal adenocarcinoma
- Fasted \>6 hours
- Able to provide informed written consent
You may not qualify if:
- Any patient \<18 years or \>90 years of age.
- Lacks capacity or is unable to provide informed written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Imperial Health Charitycollaborator
- Rosetrees Trustcollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (8)
Homerton Hospital
London, E9 6SR, United Kingdom
St Mark's Hospital
London, HA1 3UJ, United Kingdom
St George's Hospital
London, SW17 0RE, United Kingdom
Chelsea and Westminster Hospital
London, SW19 9NH, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
West Middlesex Hospital
London, TW7 6AF, United Kingdom
St Mary's Hospital
London, W2 1NY, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (1)
Woodfield G, Belluomo I, Laponogov I, Veselkov K; COBRA1 WORKING GROUP; Cross AJ, Hanna GB. Diagnostic Performance of a Noninvasive Breath Test for Colorectal Cancer: COBRA1 Study. Gastroenterology. 2022 Nov;163(5):1447-1449.e8. doi: 10.1053/j.gastro.2022.06.084. Epub 2022 Jul 5. No abstract available.
PMID: 35803311RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor George Hanna
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
George B Hanna, FRCS PhD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 9, 2018
Study Start
June 3, 2017
Primary Completion
July 1, 2020
Study Completion
April 1, 2022
Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share