qFIT + liquid biopsy for earlier diagnosis of colorectal cancer
Research type
Research Study
Full title
Development and Validation of a Novel Liquid Biopsy for Colorectal Cancer in Symptomatic Patients Referred from Primary Care with Elevated Faecal Haemoglobin
IRAS ID
306326
Contact name
Craig Mowat
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Colorectal cancer (CRC) is the fourth most common cancer in the UK and second most common cause of cancer death. The National Institute of Health and Care Excellence (NICE) recommends quantitative faecal immunochemical testing (qFIT) as a key investigation for general practitioners (GPs) in their assessment of patients with new bowel symptoms. Patients with elevated faecal haemoglobin (f-Hb) on qFIT require referral for further investigation such as colonoscopy. However, colonoscopy is invasive and requires a skilled operator and specialist equipment and therefore has significant waiting lists. This has been exacerbated further by the COVID-19 pandemic.
We aim to further stratify the risk of CRC in patients with elevated f-Hb (>400 µg Hb/g faeces) prior to colonoscopy by designing a ‘liquid biopsy’. Liquid biopsies are a popular area of current cancer research as they can provide important diagnostic and prognostic information from body fluids such as blood and urine, rather than invasive tissue biopsies. Tumours release very small amounts of DNA into blood which can be detected as cell-free circulating tumour DNA (ctDNA). This can be analysed for genetic and epigenetic changes related to tumour growth. We also plan to investigate whether adding full blood count indices (for example platelet count or haemoglobin concentration) and protein biomarkers to the liquid biopsy may improve the sensitivity and specificity.
To develop the liquid biopsy we will use blood samples provided by participants with and without CRC. For those with CRC, we will also ask for permission to use some of the surplus resected cancer tissue.
Finally, we plan to validate our liquid biopsy in a validation cohort to investigate whether it can accurately identify patients at high risk of CRC.
REC name
West of Scotland REC 1
REC reference
22/WS/0179
Date of REC Opinion
14 Dec 2022
REC opinion
Favourable Opinion