Condition category
Cancer
Date applied
16/08/2010
Date assigned
17/08/2010
Last edited
13/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
Prof Wendy S Atkin
w.atkin@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wendy S Atkin

ORCID ID

Contact details

Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3369
w.atkin@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/22/192

Study information

Scientific title

Faecal immunochemical testing for adenoma surveillance (FIT for Follow-up study)

Acronym

FIT for Follow-Up

Study hypothesis

The 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

Plan to submit to the Central London REC 1

Study design

Pragmatic accuracy and efficiency study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Bowel cancer

Intervention

People 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

1. 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 trial start date

01/01/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

8000

Participant exclusion criteria

Those who do not return a consent form

Recruitment start date

01/01/2011

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme (ref: 09/22/192)

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/04/2016: Plain English summary added.