N/A
Completed N=1,855
The Colorectal Breath Analysis (COBRA) Study
Source: ClinicalTrials.gov NCT03699163 ↗Enrolled (actual)
1,855
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Determine the Diagnostic Accuracy of the Proposed Breath Test for Detection of Colorectal Cancer in All Patients — 79; 86 percentage of true cases
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.
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 | — |
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. Informational only — not medical advice.