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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
United Kingdom
Chelsea and Westminster Hospital
RECRUITING
London
Royal Marsden Hospital
ACTIVE_NOT_RECRUITING
London
St Mark's Hospital
ACTIVE_NOT_RECRUITING
London
St Mary's Hospital
RECRUITING
London
West Middlesex University Hospital
RECRUITING
London
Contact Information
Primary
Mr Michael G Fadel, BSc MBBS MRCS
m.fadel@imperial.ac.uk
+44 (0)20 7594 3396
Time Frame
Start Date: 2022-09-23
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 720
Treatments
Control group - 470 patients
Symptomatic patients who are attending a planned colonoscopy referred under the suspected lower GI cancer pathway. Any patient who is found to have histologically-proven CRC on colonoscopy will be analysed as part of the CRC group.
CRC group - 250 patients
Patients who either have a confirmed diagnosis of colorectal adenocarcinoma according to a biopsy, or who are due to undergo surgical resection for suspected CRC (with histological confirmation to follow within three months).
Related Therapeutic Areas
Sponsors
Collaborators: London North West Healthcare NHS Trust, Chelsea and Westminster NHS Foundation Trust, Imperial College Healthcare NHS Trust, Royal Marsden NHS Foundation Trust, National Institute for Health Research, United Kingdom
Leads: Imperial College London

This content was sourced from clinicaltrials.gov