Trial Outcomes & Findings for The Colorectal Breath Analysis (COBRA) Study (NCT NCT03699163)

Last Updated: 2024-11-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1855 participants

Primary outcome timeframe

30 minutes

Results posted on

2024-11-21

Participant Flow

1855 total patients were enrolled in the study between 5/6/2017 and 21/2/2020.

The cancer/non cancer diagnosis was not known for the majority of excluded participants, because the exclusion was based upon data corruption/failure of quality control of breath sample, hence no further clinical details were recorded. Exclusions have been arbitrarily divided between both study groups for the purposes of this table.

Participant milestones

Participant milestones
Measure	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 enter this group. Breath sample: 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.	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 enter this group. Breath sample: 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.
Overall Study STARTED	1487	368
Overall Study COMPLETED	1270	162
Overall Study NOT COMPLETED	217	206

Reasons for withdrawal

Reasons for withdrawal
Measure	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 enter this group. Breath sample: 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.	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 enter this group. Breath sample: 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.
Overall Study Physician Decision	12	0
Overall Study failed QC measures	205	206

Baseline Characteristics

The Colorectal Breath Analysis (COBRA) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colorectal Cancer n=162 Participants 162 patients of the included total had a diagnosis of colorectal cancer	Non-cancer Controls n=1270 Participants 1270 patients had a non-cancer diagnosis	Total n=1432 Participants Total of all reporting groups
Age, Continuous	66.5 years n=5 Participants	63 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	540 Participants n=7 Participants	601 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	730 Participants n=7 Participants	831 Participants n=5 Participants
Race/Ethnicity, Customized Arab	5 Participants n=5 Participants	40 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Asian British	22 Participants n=5 Participants	198 Participants n=7 Participants	220 Participants n=5 Participants
Race/Ethnicity, Customized Black / African / Caribbean / Black British	19 Participants n=5 Participants	106 Participants n=7 Participants	125 Participants n=5 Participants
Race/Ethnicity, Customized Other ethnicity	8 Participants n=5 Participants	38 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Unrecorded	4 Participants n=5 Participants	30 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized White British/ European	104 Participants n=5 Participants	858 Participants n=7 Participants	962 Participants n=5 Participants
Time fasted	22 Hours n=5 Participants	24 Hours n=7 Participants	24 Hours n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Outcome measures
Measure	Detection of Colorectal Cancer in Breath in All Patients n=1432 Participants Colorectal cancer patients attending for surgery and non-cancer controls attending for colonoscopy
Determine the Diagnostic Accuracy of the Proposed Breath Test for Detection of Colorectal Cancer in All Patients Sensitivity	79 percentage of true cases
Determine the Diagnostic Accuracy of the Proposed Breath Test for Detection of Colorectal Cancer in All Patients Specificity	86 percentage of true cases

PRIMARY outcome

Timeframe: 30 minutes

Population: This a subgroup or 855 symptomatic patients taken from within the total cohort

Outcome measures

Outcome measures
Measure	Detection of Colorectal Cancer in Breath in All Patients n=855 Participants Colorectal cancer patients attending for surgery and non-cancer controls attending for colonoscopy
Determine the Diagnostic Accuracy of Using VOCs Present in Breath for the Detection of Colorectal Cancer in Symptomatic Patients Sensitivity	83 Percentage of true cases
Determine the Diagnostic Accuracy of Using VOCs Present in Breath for the Detection of Colorectal Cancer in Symptomatic Patients Specificity	88 Percentage of true cases

Adverse Events

Endoscopy Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Colorectal Cancer Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor George Hanna

Imperial College London

Phone: 02033122124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place