Dataset Information

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

ABSTRACT: 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

DISEASE(S): Bowel Cancer Surveillance,Public Health-health Service Research,Colorectal Cancer,Oral And Gastrointestinal-inflammatory Bowel Disease,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Inflammatory Bowel Disease,Pre-cancerous Colorectal Neoplasia

PROVIDER: 2470886 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Colorectal cancer (CRC) prevention programs are tailored to the degree of risk and within the Australian public health system with surveillance by colonoscopy usually reserved for those in the above average risk category. Different levels of risk, average, moderately increased and high, are recognised for population sub-groups. People with known genetic syndromes (eg familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC, also known as Lynch Syndrome] are considered to be at high risk for CRC and are advised to undergo regular (every 1-2 years) colonoscopic surveillance. We propose to conduct this uncontrolled observational study, where patients self-select to the treatment group based on their participation in a colonoscopy surveillance program - the ‘Southern Cooperative Program for the prevention of colorectal cancer’ (SCOOP), run through Flinders Medical Centre and Noarlunga Hosptial. We will approach SCOOP patients and offer a FIT (Faecal Occult Blood Test) to be completed 1 - 2 weeks prior to their scheduled colonoscopy to determine the positive predictive value (PPV), negative predictive value (NPV), specificity and sensitivity for neoplasia of FIT, in comparison to colonoscopy. The FIT kit including an invitation letter, two collection tubes, instructions and a reply paid envelope, will be posted to study invitees. Participants will be required to self-collect two small stool samples (approximately 10mg of stool which is smaller than a grain of rice) with the provided collection devices. The samples will then be placed in the collection tubes, placed in a reply paid envelope and posted back to the testing laboratory. Following return to the testing laboratory, samples will be analysed for levels of faecal haemo Primary outcome(s): 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

Dataset Information

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

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