Condition category
Cancer
Date applied
11/09/2017
Date assigned
19/12/2017
Last edited
13/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Nigel D'Souza

ORCID ID

http://orcid.org/0000-0002-9614-6113

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35915

Study information

Scientific title

NICE Guidelines and the place of the Faecal Immunochemical Test as a triage tool for predicting Bowel Cancer

Acronym

NICE FIT

Study hypothesis

Hypotheses:
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

London South East Research Ethics Committee REC,18/05/2017, ref: 16/LO/2174

Study design

Non-randomised; Interventional; Design type: Diagnosis, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Cancer, Primary sub-specialty: Colorectal Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs

Intervention

All 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 type

Other

Phase

Drug names

Primary outcome measure

1. 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 measures

1. 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 trial start date

06/01/2017

Overall trial end date

01/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 6000; UK Sample Size: 6000

Participant exclusion criteria

1. 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 date

01/04/2017

Recruitment end date

01/11/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mayday University Hospital
Croydon Health Services NHS Trust London Road
Thorton Heath
CR7 7YE
United Kingdom

Trial participating centre

St Marys Hospital
Imperial College Healthcare NHS Trust Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Chelsea & Westminster Hospital
Chelsea & Westminster Hospital NHS Foundation Trust 369 Fulham Road
London
SW10 9NH
United Kingdom

Trial participating centre

The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road Middlesex
Uxbridge
UB8 3NN
United Kingdom

Trial participating centre

Northwick Park Hospital
London North West Healthcare NHS Trust Watford Road
Harrow
HA1 3UJ
United Kingdom

Trial participating centre

Kingston Hospital NHS Foundation Trust
Galsworthy Road
Kingston Upon Thames
KT2 7QB
United Kingdom

Trial participating centre

St George's Hospital
St George's University Hospital NHS Foundation Trust Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom

Trial participating centre

St Helier Hospital
Epsom and St Helier University Hospitals NHS Trust Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

St Peter's Hospital
Ashford and St Peter's Hospital Guildford Road
Chertsey
KT16 0PZ
United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill King's College Hospital NHS Foundation Trust
London
SE5 9RS
United Kingdom

Trial participating centre

University Hospital Lewisham
Lewisham and Greenwich NHS Trust Lewisham High Street
London
SE13 6LH
United Kingdom

Trial participating centre

Worthing Hospital
Western Sussex Hospitals NHS Foundation Trust Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Trial participating centre

Kent & Canterbury Hospital
East Kent Hospitals University NHS Foundation Trust Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Trial participating centre

East Surrey Hospital
Surrey and Sussex Healthcare NHS Trust Canada Avenue
Redhill
RH1 5RH
United Kingdom

Trial participating centre

Salisbury District Hospital
Salisbury NHS Foundation Trust Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Hampshire Hospitals NHS Foundation Trust
Aldermaston Road Hampshire
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

Dorset Healthcare University NHS Foundation Trust
Sentinel House 4-6 Nuffield Road Nuffield Industrial Estate Poole Dorset
Poole
BH17 0RB
United Kingdom

Sponsor information

Organisation

Croydon Health Services NHS Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NHS England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alpha Laboratories Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The 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 statement:
The 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).

Intention to publish date

31/12/2018

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.