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Assessing the diagnostic performance of faecal occult blood testing, against colonoscopy, in people at elevated risk for bowel cancer.

ABSTRACT: 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

DISEASE(S): Public Health-health Service Research,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2467801 | 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. All potential participants will be taken from the ‘Southern Cooperative Program for the Prevention of Colorectal Cancer’ (SCOOP) which is a clinical database which consisting of individuals with a family history of CRC or a personal history of neoplasia, and who have their surveillance colonoscopies through two South Australian public hospitals and selected private hospitals. Commencing in 1999, this program currently has 7000 people enrolled and is made up of gastroenterologists, geneticists, nurses and support administrative staff and is coordinated from the Bowel health Service (BHS) at Flinders Centre for Innovation in Cancer (FCIC), Flinders Medical Centre. SCOOP also has a research arm to help improve the program and improve patient outcomes. It is estimated that there will be 4,500 eligible individuals from the SCOOP population, who will have a surveillance colonoscopy planned between the 2019 and 2023. Colonoscopy intervals are decided by the SCOOP team of specialists in conjunction with the National Health and Medical Research Council (NHMRC) ‘Clinical practice guidelines for surveillance colonoscopy’ 2018. As part of the program, SCOOP individuals are provided with a ‘Faecal Immunochemical Test’ (FIT) kit in the interval between their 3 or 5 yearly colonoscopies. Those with a 3 year colonoscopy interval will have an offer of FIT at 1 year and those with a 5 year colonoscopy interval will have an offer of FIT at 1 yea Primary outcome(s): To determine the safety of extending colonoscopy schedules by one-third, in intervention arm, by including interval Faecal Immunochemical Test (FIT) as evidenced by the decreased presence of advanced neoplasia as assessed by colonoscopy.[Group 1: Intervention arm - Assessed 6 months post colonoscopy.];Burden of having a colonoscopy as assessed by study-specific colonoscopy costing survey. [All participants in Group 1 only: Assessed 6 months post colonoscopy.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy

Project description:Interventions: Eligible people (n = 240) within the SCOOP program (a colonoscopy surveillance program for individuals at higher risk for bowel cancer) at Repatriation General Hospital or Flinders Medical Centre who do not screen for bowel cancer via the standard means (ie. faecal testing), will be sent a letter to invite them to screen for bowel cancer with a blood test (Colovantage Plasma), as well as a short survey to ascertain their demographic details and their screening history. Anyone interested in taking up the blood screening test will be asked to fill in the consent form and request form and send them back (in the provided reply paid envelope) to the Bowel Health Service. Following receipt of the blood test request form, the study enrolee will then be sent further information on the blood test (including information on the accuracy of the test, where they can get their blood collected, and when they will receive their test results) and a test referral. They can then take up the offer of the free screening blood test at one of four local blood collection centres (Healthscope). They do not need to be fasted and appointments do not need to be made. Reminder letters will be sent after 6 weeks to those people who have not taken up the blood test screening offer. Screening participation rate with the blood test and demographic factors that influence uptake, will be assessed at the 12 week time point. Primary outcome(s): The primary outcome is to determine how many people within 12 weeks following the invitation letter have a blood sample collected for bowel cancer screening (ie. outcome = blood test participation rate). The number that complete the blood test will be expressed as a percentage of the invited cohort (ie. 240)[12 weeks after invitation to screen.];An additional primary outcome will be to determine the factors that predict screening uptake with the blood test, ie. age, gender, risk status for bowel cancer, reasons for not participating with faecal testing. This information will be established via a short survey (designed specifically for this study) that is provided with the original study invitation letter.[12 weeks after invitation to screen.] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

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Assessing the diagnostic performance of faecal occult blood testing, against colonoscopy, in people at elevated risk for bowel cancer.

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