The Colorectal Breath Analysis (COBRA) Study

Colorectal Cancer Clinical Trial

— COBRA  

Official title:

Non-invasive Testing for the Diagnosis and Assessment of Colorectal Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03699163
• Other study ID #: 17SM3783
• Status: Active, not recruiting
• Start date: June 3, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Colorectal cancer is the 2nd most common cause of cancer death in the UK where survival rates are among the lowest in Europe. If diagnosed early survival may exceed 90%.

The proposed breath test is a non-invasive investigation that can detect the presence of volatile organic compounds (VOCs) in breath and their relative abundance in disease states including colorectal cancer. This test has potential to be used in a primary care setting to identify patients at high risk of colorectal cancer, supporting earlier referral for definitive investigation. A negative test may provide reassurance to patients and prevent unnecessary tests in this group. The test could also have an application for colorectal cancer screening.

In this study the investigators will determine the diagnostic accuracy of an exhaled breath test for the detection of colorectal adenocarcinoma and colonic polyps. To determine the accuracy of the breath test a multicentre cross-sectional study will be conducted to analyse single breath samples from patients attending hospital for planned colonoscopy or elective resection of histologically confirmed colorectal cancer. The target for the study is 1463 patients.

Breath collection will be conducted using a previously validated method. Samples of breath (500ml) collected using a CE-marked handheld ReCIVA sampling device (Owlstone Medical Ltd., Cambridge, UK) during a period of tidal breathing (approximately 5minutes) will be absorbed onto thermal desorption tubes (Markes International, Llantrisant, UK). All patients will have received bowel preparation and will be fasted for a minimum of 6 hours prior to the breath sample. Breath samples collected within thermal desorption tubes will be transferred to a central laboratory for analysis by gas chromatography mass spectrometry (GC-MS) and proton transfer reaction time of flight mass spectrometry (PTR-ToF-MS). Raw data files will be extracted and analysed in accordance with established protocols. Quality assurance measures will be formally assessed at each stage of sample handling.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1757
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 <18 years or >90 years of age.

• Lacks capacity or is unable to provide informed written consent.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma
• Colorectal Cancer
• Colorectal Polyps

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Homerton Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	St Mark's Hospital	London
United Kingdom	St Mary's Hospital	London
United Kingdom	West Middlesex Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
Imperial College London	Imperial Health Charity, National Institute for Health Research, United Kingdom, Rosetrees Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the diagnostic accuracy of the proposed breath test for detection of colorectal cancer and colorectal polyps.	Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of colorectal cancer and polyps. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability.	4 years
Secondary	Confirmation of diagnostic accuracy of the proposed breath test for early detection of colorectal cancer and for colorectal polyps.	After diagnostic accuracy has been determined as per objective 1 by the discovery phase of the proposed study, a validation phase will then follow to confirm findings. Diagnostic accuracy of the validation phase results will be measured by calculating the sensitivity and specificity of the test for detection of colorectal cancer and polyps. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability.	2 years