Trial Details

Recruiting
Basic Information
Clinical ID c2525
Identifier ACTRN12620000668909
Trial Title Determining the accuracy of non-invasive biomarkers for detecting pre-cancerous colorectal neoplasia
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Bowel Cancer Surveillance;Colorectal Cancer;Inflammatory Bowel Disease;Pre-cancerous colorectal neoplasia; Bowel Cancer Surveillance Colorectal Cancer Inflammatory Bowel Disease Pre-cancerous colorectal neoplasia;Cancer - Bowel - Back passage (rectum) or large bowel (colon);Public Health - Health service research;Oral and Gastrointestinal - Inflammatory bowel disease
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.
Participant Information
Sponsor Flinders University of South Australia
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -