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

ISRCTN ISRCTN18040196
DOI https://doi.org/10.1186/ISRCTN18040196
Secondary identifying numbers HTA 09/22/192
Submission date
16/08/2010
Registration date
17/08/2010
Last edited
06/05/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Most bowel cancers develop from adenomas, a type of small growth that grows on the bowel wall. Removing adenomas can help to prevent the development of cancer. The NHS now offers screening for bowel cancer to all men and women aged between 60 and 69 years and from 2010, the age range will be extended to 74 years. The screening test, called FOBT, looks for traces of blood in the stool. People who have a positive FOBT are offered colonoscopy, an examination in which an endoscope is used to examine the lining of the bowel for cancers and polyps. Those who have large or multiple adenomas found at colonoscopy are known to have an increased risk of developing more adenomas and possibly bowel cancer. Therefore they are currently offered surveillance colonoscopy at 3 year intervals. There are a number of problems with this approach. Colonoscopy is a costly procedure requiring a skilled doctor, and it carries a small risk of serious complications. It can miss lesions - indeed most advanced lesions (large adenomas or cancers) found at follow-up examinations were present but missed at the previous colonoscopy. Surveillance colonoscopy is also wasteful of resources because significant lesions are found in only about 3% of examinations, so 97% of surveillance colonoscopies will find either nothing or only small harmless adenomas. This is reassuring to the patient but offers no real benefit. Because more adenomas are now being found as a result of the NHS Bowel Cancer Screening Programme (BCSP), the number of surveillance colonoscopies is increasing and threatens to overwhelm available resources. A more cost-effective way of protecting people with higher-risk adenomas is required. We propose that a new type of stool test (faecal immunological test, FIT) could offer effective protection for this higher-risk group at a fraction of the cost. Only patients who had a positive FIT result would need to be offered colonoscopy. This study is designed to estimate the benefit of this approach.

Who can participate?
People who have taken part in the Bowel Cancer Screening Programme (BCSP) and have been diagnosed with large or multiple adenomas

What does the study involve?
Participants are offered the FIT at 1, 2 and 3 years. The test is very simple, requiring participants to collect a tiny amount of stool on a probe and return to the laboratory (easier than the FOBT which requires 6 stool samples). Participants who have a positive FIT result are offered a colonoscopy immediately and their next colonoscopy will be three years later. Those who do not test positive to any of the three annual FITs have their colonoscopy at 3 years in the usual way. We compare the total number of bowel lesions found in people who test positive at the 1st, 2nd or 3rd FITs with the number of lesions found at 3-year colonoscopy in those who had a negative FIT result. If most important lesions are found in the group who have positive FIT results, this would suggests that this new approach could provide effective protection and ultimately mean that colonoscopy could be used only in cases with a positive FIT result.

What are the possible benefits and risks of participating?
Participants who have a positive FIT results at Years 1 or 2 will be offered a colonoscopy early and some of them will have no adenomas detected, so it will not benefit them, but some participants will have important lesions found that would otherwise not be detected until 3 years and therefore will derive benefit. The FIT test will be offered in addition to the 3-year colonoscopy which is the current procedure and we will not be replacing their colonoscopy, so the risk of missing lesions is not increased.

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
January 2011 to December 2015

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Current main contact as of 13/02/2019:
Dr Amanda Cross, amanda.cross@imperial.ac.uk
Previous main contact:
Prof Wendy S Atkin, w.atkin@imperial.ac.uk

Study website

Contact information

Dr Amanda Cross
Scientific

Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom

ORCiD logoORCID ID 0000-0002-0893-2377
Phone +44 (0)20 7594 3401
Email amanda.cross@imperial.ac.uk

Study information

Study designPragmatic accuracy and efficiency study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleFaecal immunochemical testing for adenoma surveillance (FIT for Follow-up study)
Study acronymFIT for Follow-Up
Study hypothesisThe overall objective is to test the hypothesis that annual immunochemical faecal occult blood testing (iFOBT or FIT) is a feasible, safe, acceptable and cost-saving alternative to colonoscopy surveillance for the diagnosis of advanced adenomas (AA) and early stage colorectal cancer (CRC) in patients with intermediate risk colorectal adenomas.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0922192
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/54340/PRO-09-22-192.pdf
Ethics approval(s)Approved 23/05/2019, London – City and East REC (St Bartholomew's Hospital, North Wing, London, EC1A 7BE, UK; +44 (0)207 104 8171; cityandeast.rec@hra.nhs.uk), ref: 11/LO/0326
ConditionBowel cancer
InterventionPeople who have taken part in the BCSP and been diagnosed with large or multiple adenomas will be offered the FIT annually at 1, 2 and 3 years. People participating in this study who have a positive FIT will be offered a colonoscopy immediately and their next colonoscopy will be three years later. Those who do not test positive to any of the three annual FITs will have their colonoscopy at 3 years in the usual way.

Patients will receive a Patient Acceptability and Mental Well Being Questionnaire in Years 1 and 2. In Year 3, remaining patients will receive an End of Study Questionnaire that will include an additional set of questions on preferences for annual FIT vs. 3-yearly colonoscopy.
Intervention typeOther
Primary outcome measureThe 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 measures1. Completion and positivity rates for 1st, 2nd and 3rd annual FITs
2. Positive predictive values for detection of CRC/AA at the 1st, 2nd and 3rd FIT screenings in patients who undergo colonoscopic investigation
3. Detection rate of CRC/AA at the 3-year colonoscopy in patients who test negative at the 1st, 2nd and 3rd FIT screenings
4. Preference for annual FIT vs. 3-yearly colonoscopy for surveillance
5. Quality of life scores and subjective health status
6. Incremental costs and cost-effectiveness of the annual FIT vs. 3-yearly colonoscopy surveillance
Overall study start date01/01/2011
Overall study end date31/12/2015

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants8000
Total final enrolment8009
Participant inclusion criteria1. 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.
Participant exclusion criteriaThose who do not return a consent form
Recruitment start date01/01/2011
Recruitment end date31/12/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Imperial College London
London
W2 1PG
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Clinical Research Governance Office
G02, Sir Alexander Fleming Building
South Kensington campus
London
SW7 2AZ
England
United Kingdom

Website http://www3.imperial.ac.uk/
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

Health Technology Assessment Programme (ref: 09/22/192)
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results interim results in conference proceedings: 01/06/2015 No No
Results article results 01/06/2018 Yes No
Results article results 01/01/2019 Yes No
Results article results 01/01/2019 Yes No
Results article results 01/09/2019 Yes No
Abstract results Oral presentation for British Society of Gastroenterology 2014 Annual Meeting 09/06/2014 05/05/2022 No No
Abstract results abstract for British Society of Gastroenterology 2013 Annual Meeting 04/06/2013 05/05/2022 No No
Results article Patient attitudes towards faecal immunochemical testing 17/09/2013 05/05/2022 Yes No
Results article Public preferences for colorectal surveillance 13/09/2016 05/05/2022 Yes No

Editorial Notes

06/05/2022: The ethics approval has been added.
05/05/2022: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added.
13/02/2019: The following changes were made:
1. The scientific contact was changed
2. The plain English summary was updated
3. The basic results (scientific) were added
4. Three publication references were added
09/01/2019: Publication reference added.
31/05/2018: Conference proceedings added. Trial website added.
13/04/2016: Plain English summary added.