Determining the accuracy of non-invasive biomarkers for detecting pre-cancerous colorectal neoplasia

Interventions: This study will discover and develop novel blood & stool biomarkers. Biomarkers will be evaluated for both their ability and acceptability to detect inflammation, adenomas, and cancer in patients with gastrointestinal symptoms. The development of new screening tests will help guide doctors in determining which symptomatic patients need colonoscopy.
People experiencing gastrointestinal symptoms, have had a microscopic rectal bleed (by indication of a positive faecal occult blood test), or living with inflammatory bowel disease who are booked for a colonoscopy at our study sites will be pre-screened for eligibility.
An invitation letter will be sent to eligible individuals, accompanied by a faecal immunochemical test (FIT) kit, questionnaire, and participant information & consent form. Participants may be met before their colonoscopy appointment by a member of the research team to have a short medical history interview & a blood sample taken. Participants may also provide a stool sample prior to their colonoscopy. Samples of tissue (biopsies) may be requested from colonoscopy by opt-in consent.
Candidate biomarkers (which indicate presence of pathological change in the bowel) will be identified from molecular analyses on tissue samples. Stool and blood samples will be subsequently analysed to determine the lead biomarkers, with results compared to the findings at colonoscopy.
Primary outcome(s): Blood biomarker levels (BCAT1 and IKZF1) will be assessed as a composite outcome, to indicate the presence of adenoma. [assessed within 1 - 2 weeks before colonoscopy.];Faecal haemoglobin level as assessed by FIT test.[assessed within 1 - 2 weeks before the colonoscopy.]
Study Design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective