COlorectal BReath Analysis (COBRA2)

Colorectal Cancer Clinical Trial

Official title: The COlorectal BReath Analysis (COBRA2) Study: Non-invasive Testing to Detect Colorectal Cancer

Status Recruiting

Clinical Trial Summary

Colorectal cancer (CRC) is the second most common cause of cancer death in the United Kingdom, with approximately 17,000 deaths per year. The five-year survival rate from CRC is only 10% when discovered at a late stage, but exceeds 90% if diagnosed early. Symptoms related to CRC can be non-specific, therefore the decision to refer for a colonoscopy can be challenging.

There is a clear need to improve earlier detection of CRC so that patients with CRC can be identified earlier and faster, enabling them to start treatment more quickly.

The study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that are specific to CRC. For patients with non-specific symptoms, this test would help GPs to identify those patients that may have underlying CRC, who would benefit from referral for specialised CRC tests.

Clinical Trial Description

The COBRA1 study initially assessed VOCs in CRC and identified a list of 14 VOC biomarkers for CRC and provided a detection model with an area under the receiver operating characteristic curve of 0.91, sensitivity of 83% and specificity of 88% in symptomatic patients.

COBRA2 therefore has the following aims:

(i) validate VOC biomarkers for CRC identified in COBRA1; (ii) further discovery of VOC biomarkers for CRC using an improved methodology and technology; (iii) refine the detection model with internal validation; (iv) exploratory comparison between a breath test and faecal immunochemical test (FIT); and assessment of the performance of combining both tests to detect CRC.

Methods: COBRA2 is be a prospective, multicentre validation study. The study team are recruiting the following patients:

• Control group: symptomatic patients who are attending for a planned colonoscopy referred under the two-week wait pathway. Any patients who is found to have histology proven CRC on colonoscopy will be analysed as part of the CRC group.

• CRC group: patients who are scheduled to undergo elective resection of histologically confirmed colorectal adenocarcinoma.

Target recruitment is 720 patients (470 controls, 250 CRC), aiming for 576 patients (376 controls, 200 CRC) with reliable and complete data. Participants are required to maintain a clear fluid diet for a minimum of 4 hours prior to sampling and should not have received bowel preparation. Participants will be asked to provide breath samples by exhaling into single-use breath collection bags and breath will be transferred using a precision pump onto thermal desorption (TD) tubes. Breath samples will be analysed with gas chromatography-mass spectrometry in accordance with existing quality control processes. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT05844514
• Study type: Observational
• Source: Imperial College London
• Contact: Mr Michael G Fadel, BSc MBBS MRCS
• Phone: +44 (0)20 7594 3396
• Email: m.fadel@imperial.ac.uk
• Status: Recruiting
• Start date: September 23, 2022
• Completion date: April 1, 2025