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

Inclusion Criteria7

Patients aged ≥ 18 years referred from primary care with symptoms of suspected CRC.
Patients with histologically confirmed colorectal adenocarcinoma (stages I-IV) who are treatment naïve (CRC group).
Previous surgery altering the anatomy of the lower GI tract (e.g., hemicolectomy, anterior resection).
Previous treatment (neoadjuvant chemotherapy or radiotherapy or immunotherapy) for CRC.
Received bowel preparation for their colonoscopy procedure.
History of any other cancer within three years.
Unable or unwilling to provide informed written consent.

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.