FIT for purpose: personalised surveillance colonoscopy for people at increased risk of colorectal cancer.
- Conditions
- Bowel cancer surveillanceColorectal CancerCancer - Bowel - Back passage (rectum) or large bowel (colon)Public Health - Health service research
- Registration Number
- ACTRN12619001743156
- Lead Sponsor
- Flinders University of South Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 4500
Inclusion Groups 1 & 2:
•Males and females enrolled in the SCOOP clinical CRC surveillance program.
•Aged older than 18 years.
•Individuals who have either had a previous colonoscopy finding of adenoma or those with a significant family history of colorectal cancer (CRC).
•Individuals with a colonoscopy surveillance interval of at least three years.
Further inclusion for Group 1 only: (to be randomised into control or intervention arms)
•Those due for surveillance colonoscopy 2019 to 2023.
•Individuals with a zero FIT result within the last 3 years.
Further inclusion for Group 2 only: (for a single survey)
•Individuals not scheduled for a surveillance colonoscopy during the study period.
Exclusion:
•Individuals under 18 years of age.
•Individuals with a familial syndrome or inflammatory bowel disease (IBD).
•Individuals who have had bowel cancer surgery with resection.
•Individuals with the indication for colonoscopy being a positive interval FIT.
•Individuals with a colonoscopy surveillance interval less than three years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Burden of having a colonoscopy as assessed by study-specific colonoscopy costing survey.<br><br>[ All participants in Group 1 only: Assessed 6 months post colonoscopy.];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.]
- Secondary Outcome Measures
Name Time Method Participant acceptance of extending colonoscopy surveillance intervals as assessed from the Discrete Choice Experiment Surveys before and after colonoscopy.[ All participants in Group 1 only: Assessed 6 months post colonoscopy.]