RecruitingACTRN12620000668909

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

Sponsor

Flinders University of South Australia

Enrollment

5,000 participants

Start Date

Jun 24, 2020

Study Type

Observational

Conditions

Pre-cancerous colorectal neoplasia Inflammatory Bowel Disease

Summary

The purpose of this study is to develop new and simple ways to screen which patients with bowel symptoms, inflammation, or anaemia will need a colonoscopy using a novel biomarker test. These results can help reduce the need for colonoscopy, and prioritising it for those that need it most. Who is it for? You may be eligible for this study if you are an adult who is booked for a colonoscopy at participating hospitals for any indication. Study details: After completing a consent form, participants may be provided a faecal immunochemical test (FIT) kit and questionnaire for completion. Participants may also be met before their colonoscopy to have a short medical history interview & blood sample taken. Optionally, tissue samples may also be requested from the colonoscopy, Samples will be analysed for biomarkers which might indicate that there is inflammation, cancer, or polyp in the bowel. Biomarker results will be compared to colonoscopy findings. Sometimes there are long waiting lists for colonoscopies. The development of novel biomarker tests will help guide doctors in determining which patients need colonoscopy.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Colonoscopy is the gold standard for detecting bowel cancer and pre-cancerous polyps, but demand far exceeds capacity, resulting in long waiting lists. Not everyone waiting for a colonoscopy actually has significant bowel disease, and better ways to identify which patients genuinely need it most could help reduce unnecessary procedures and prioritise those at highest risk. This study is developing and testing new blood and stool biomarker tests — measurable substances in the body that indicate inflammation, cancer, or polyps — to see how accurately they can predict the results of a colonoscopy. Participants provide a stool sample, give blood, and optionally have tissue samples taken during their colonoscopy. These results are then compared to what the colonoscopy actually finds. You may be eligible if you are 18 or older and are already booked for a colonoscopy at one of the participating hospitals for any reason. You simply need to be willing to provide a blood sample and/or stool sample. There are no exclusion criteria for this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 undergoing colonoscopy for any reason, such as experiencing gastrointestinal symptoms, having had a microscopic rectal bleed (by indication of a faecal occult blood test), inflammatory bowel disease, bowel cancer surveillance etc., will be pre-screened for eligibility. Patients undergoing colonoscopies at the Southern Adelaide Local Health Network (Flinders Medical Centre, Noarlunga Health Service), Central Adelaide Local Health Network (Royal Adelaide Hospital, The Queen Elizabeth Hospital) and Private Hospitals (Tennyson Centre Day Hospital) will be invited. A text message invite will be sent to eligible individuals, and if they agree to further contact, a study pack will be sent to them. The study pack will contain an invitation letter, participant information and consent form, health questionnaire and two faecal immunochemical test (FIT) kits or a FIT kit and a new rapid antigen bowel screening test. 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. Left-over tissue samples collected from participants as part of clinical care may also be accessed. 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.