New bioMarkers tO straTIfy cOlorectal caNcer referrals (MOTION study)
Research type
Research Study
Full title
Plasma biomarkers in stratifying patients referred via the lower gastro-intestinal (LGI)suspected cancer two-week wait (2WW) pathway
IRAS ID
321809
Contact name
Mohamed/A Thaha
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We will conduct prospective, observational, cohort study in a single hospital trust in the UK. We aim to determine the ability of progastrin (PG) (a type of protein) level in patients’ blood sample to rule out colorectal cancer (CRC). Also we will identify and evaluate transposable elements (TEs) in the plasma of these patients. We will approach consecutive patients who were referred to the ‘2-week wait CRC pathway’ by their general practitioners due to high-risk symptoms. After confirming the eligibility criteria for the study, we will explain the study objectives and will draw 20 mL blood sample from patients who give consent to participate in the study. This is the only additional intervention required for the study. We will avoid additional hospital visits by collecting the blood sample when the patient attends the hospital for their colonoscopy or CT scan (CT Colon) tests. We will recruit a total of 582 consecutive patients for the study. The blood sample will be processed by separating the plasma, which will be stored in the laboratory and analysed for PG levels as well as TEs later. The biomarker levels results will be correlated with the outcomes of 2ww tests in patients with and without CRC. This will help us to determine the value of PG and TEs in ruling out CRC in patients referred to the 2-week wait CRC pathway. The hospitals standard care pathway will be followed for all patients and the results of the study will not be used to make any alterations in the standard care for the patients recruited. Post-study a patient questionnaire survey exploring the patient preferred characteristics and choices of 2WW CRC diagnostic test(s) will be distributed. Patient experience of a blood-based test will be explored in detail and compared against other commonly used but more invasive tests.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0416
Date of REC Opinion
24 Apr 2025
REC opinion
Further Information Favourable Opinion