FIT for Follow-Up: a new type of stool test (faecal immunochemical test [FIT]) may offer more effective protection for people at higher risk of bowel cancer

Not Applicable

Completed

• Conditions: Cancer; Bowel cancer; Malignant neoplasm of other and ill-defined digestive organs

• Registration Number: ISRCTN18040196
• Lead Sponsor: Imperial College London (UK)

Brief Summary

2015 Abstract results in http://gut.bmj.com/content/64/Suppl_1/A365.2 interim results in conference proceedings: 2018 Results article in https://gut.bmj.com/content/67/Suppl_1/A222.2 results 2019 Results article in https://doi.org/10.3310/hta23010 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30618357 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30538097 results 2014 Abstract results in http://dx.doi.org/10.1136/gutjnl-2014-307263.42 Oral presentation for British Society of Gastroenterology 2014 Annual Meeting (added 05/05/2022) 2013 Abstract results in https://gut.bmj.com/content/62/Suppl_1/A139.1 abstract for British Society of Gastroenterology 2013 Annual Meeting (added 05/05/2022) 2013 Results article in https://pubmed.ncbi.nlm.nih.gov/24045920/ Patient attitudes towards faecal immunochemical testing (added 05/05/2022) 2016 Results article in https://pubmed.ncbi.nlm.nih.gov/27618798/ Public preferences for colorectal surveillance (added 05/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-17
• Study Completion: 2015-12-31
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8009

Inclusion Criteria

1. Men and women aged 60-75 years
2. Tested positive in the NHS Bowel Cancer Screening Programme (BCSP)
3. Had colonoscopy at which intermediate risk adenomas were removed during the past year
4. Were told they required a colonoscopy at 3 years
We will invite eligible participants from the entire BCSP however recruitment will be coordinated by one centre.

Exclusion Criteria

Those who do not return a consent form

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cumulative yield of CRC/AA in those testing positive on any one of the 3 annual FITs, relative to the total CRC/AA (those testing positive on any of the FITs plus additional CRC/AA cases detected at the 3-year colonoscopy in those testing negative at all 3 FITs). From this we can calculate the proportion of cases which would go undetected if the FIT regimen was standard.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Completion and positivity rates for 1st, 2nd and 3rd annual FITs<br> 2. Positive predictive values for detection of CRC/AA at the 1st, 2nd and 3rd FIT screenings in patients who undergo colonoscopic investigation<br> 3. Detection rate of CRC/AA at the 3-year colonoscopy in patients who test negative at the 1st, 2nd and 3rd FIT screenings<br> 4. Preference for annual FIT vs. 3-yearly colonoscopy for surveillance<br> 5. Quality of life scores and subjective health status<br> 6. Incremental costs and cost-effectiveness of the annual FIT vs. 3-yearly colonoscopy surveillance<br>