RecruitingNCT05844514

COlorectal BReath Analysis (COBRA2)

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

Sponsor

Imperial College London

Enrollment

720 participants

Start Date

Sep 23, 2022

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a simple breath test can help detect colorectal cancer (bowel cancer) early, without needing invasive procedures. Researchers want to see if chemicals in your breath can reveal signs of cancer. **You may be eligible if...** - You are 18 or older - You have been referred by your GP with symptoms that might suggest bowel cancer, OR you have a confirmed diagnosis of colorectal cancer and have not yet started treatment **You may NOT be eligible if...** - You have had previous surgery that changed the layout of your lower bowel (such as removal of part of the colon) - You have already received chemotherapy, radiation, or immunotherapy for bowel cancer - You took bowel prep before a colonoscopy - You have had another type of cancer in the past three years - You are unable or unwilling to give written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBreath test

Patients must be fasted for a minimum of 4-6 hours prior to breath sample collection. For patients undergoing colonoscopy or surgery, breath samples must be obtained prior to patients receiving bowel preparation in either outpatient clinic or pre-assessment clinic.