FIT— Can a Dipstick Test Rule Out Bowel Cancer?

ISRCTN ISRCTN49676259
DOI https://doi.org/10.1186/ISRCTN49676259
Secondary identifying numbers 35915
Submission date
11/09/2017
Registration date
19/12/2017
Last edited
18/01/2023
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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-new-test-called-fit-to-look-for-signs-of-bowel-cancer-nice-fit

Contact information

Mr Nigel D'Souza
Scientific

Academic Colorectal Unit
Croydon University Hospital
Croydon
CR7 7YE
United Kingdom

ORCiD logo 0000-0002-9614-6113

Study information

Study designNon-randomised; Interventional; Design type: Diagnosis, Device
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN49676259_PIS_V4.1_25May17.pdf
Scientific titleNICE Guidelines and the place of the Faecal Immunochemical Test as a triage tool for predicting Bowel Cancer
Study acronymNICE FIT
Study hypothesisHypotheses:
1. To investigate whether FIT can be used as an effective triaging tool in primary care to decide whether patients referred under the two week rule should undergo endoscopic investigation.
2. To determine appropriate cut-off levels for subgroups based on age, sex, ethnicity and socioeconomic deprivation
Ethics approval(s)London South East Research Ethics Committee REC,18/05/2017, ref: 16/LO/2174
ConditionColorectal Cancer
InterventionAll participants recruited in the study are asked to complete a stool sample, and return it to the laboratory for FIT analysis. The faecal haemoglobin level are compared to the findings from the colonoscopy.
Intervention typeOther
Primary outcome measure1. Identify a suitable cut-off for the test
2. Calculate the sensitivity of the test using the chosen cut-off for colorectal polyps
Secondary outcome measures1. Calculate the specificity, negative- and positive-predictive values for the chosen cutoff
2. Explore the effects of other prognostic factors on the sensitivity and the suitability of the cut-off value:
2.1. Cancer site
2.2. Site and size of adenomas
3. Assessing the levels of FHb in benign non-neoplastic pathology

The above data will be collected from reviewing patient notes and correlated with the faecal haemoglobin detected by the lab.
Overall study start date06/01/2017
Overall study end date01/06/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 6000; UK Sample Size: 6000
Total final enrolment9822
Participant inclusion criteria1. All patients referred under the 2WW urgent referral system and triaged for a colonoscopy examination
2. 18 years of age or older
3. Willing to provide informed consent
Participant exclusion criteria1. Unable to undergo colonoscopy
2. Unable to take adequate stool sample (including those taken during bowel preparation)
3. Unable to give an informed consent due to lack of capacity
4. Unable to give informed consent because of language barrier, when a relative over 18 is unable to translate, a staff member who speaks the same language cannot be found, or online translation service are unsuccessful
Recruitment start date01/04/2017
Recruitment end date31/03/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Mayday University Hospital
Croydon Health Services NHS Trust
London Road
Thorton Heath
CR7 7YE
United Kingdom
St Marys Hospital
Imperial College Healthcare NHS Trust
Praed Street
London
W2 1NY
United Kingdom
Chelsea & Westminster Hospital
Chelsea & Westminster Hospital NHS Foundation Trust
369 Fulham Road
London
SW10 9NH
United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road
Middlesex
Uxbridge
UB8 3NN
United Kingdom
Northwick Park Hospital
London North West Healthcare NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom
Kingston Hospital NHS Foundation Trust
Galsworthy Road
Kingston Upon Thames
KT2 7QB
United Kingdom
St George's Hospital
St George's University Hospital NHS Foundation Trust
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom
St Helier Hospital
Epsom and St Helier University Hospitals NHS Trust
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
St Peter's Hospital
Ashford and St Peter's Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom
King's College Hospital
Denmark Hill
King's College Hospital NHS Foundation Trust
London
SE5 9RS
United Kingdom
University Hospital Lewisham
Lewisham and Greenwich NHS Trust
Lewisham High Street
London
SE13 6LH
United Kingdom
Worthing Hospital
Western Sussex Hospitals NHS Foundation Trust
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Kent & Canterbury Hospital
East Kent Hospitals
University NHS Foundation Trust
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
East Surrey Hospital
Surrey and Sussex Healthcare NHS Trust
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Salisbury District Hospital
Salisbury NHS Foundation Trust
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Hampshire Hospitals NHS Foundation Trust
Aldermaston Road
Hampshire
Basingstoke
RG24 9NA
United Kingdom
Dorset Healthcare University NHS Foundation Trust
Sentinel House
4-6 Nuffield Road
Nuffield Industrial Estate Poole Dorset
Poole
BH17 0RB
United Kingdom

Sponsor information

Croydon Health Services NHS Trust
Hospital/treatment centre

Croydon University Hospital
London Road
Thornton Heath
CR7 7YE
England
United Kingdom

ROR logo https://ror.org/00sh7p618

Funders

Funder type

Government

NHS England

No information available

Alpha Laboratories Limited

No information available

Results and Publications

Intention to publish date01/06/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination planThe data will be published upon study completion. Submission for publication in a high impact journal should hopefully occur before December 2018. It will be presented at national and international conferences.
Data will be shared with NHS England, who will pool it with data from other FIT trials.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (at Croydon University Hospital, that will be shared with NHS England only).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V4.1 25/05/2017 19/12/2017 No Yes
Results article results 21/10/2020 23/10/2020 Yes No
Other publications Patient survey substudy 22/03/2022 18/01/2023 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN49676259_PIS_V4.1_25May17.pdf
Uploaded 19/12/2017

Editorial Notes

18/01/2023: Publication reference added.
23/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
02/06/2020: The intention to publish date was changed from 01/10/2019 to 01/06/2020.
29/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Colorectal Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs" to "Colorectal Cancer" following a request from the NIHR.
06/12/2018: The following changes were made:
1. The recruitment end date has been updated from 01/11/2018 to 31/03/2019.
2. The overall trial end date has been updated from 01/04/2019 to 01/06/2019.
3. The intention to publish has been updated from 31/12/2018 to 01/10/2019.
13/06/2018: Cancer Research UK lay summary link added to plain English summary field
14/05/2018: Internal review.
16/01/2018: Internal review.

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