N/A
N=1,855
The Colorectal Breath Analysis (COBRA) Study
Colorectal Cancer · Colorectal Polyps · Colorectal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03699163 ↗Enrolled (actual)
1,855
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Determine the Diagnostic Accuracy of the Proposed Breath Test for Detection of Colorectal Cancer in All Patients — 79; 86 percentage of true cases
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Breath sample (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Diagnostic Accuracy of the Proposed Breath Test for Detection of Colorectal Cancer in All Patients |
79; 86 | — |
| PRIMARY Determine the Diagnostic Accuracy of Using VOCs Present in Breath for the Detection of Colorectal Cancer in Symptomatic Patients |
83; 88 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥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
Exclusion Criteria
- Any patient 90 years of age.
- Lacks capacity or is unable to provide informed written consent.
Data sourced from ClinicalTrials.gov (NCT03699163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.