FIT— Can a Dipstick Test Rule Out Bowel Cancer?
| ISRCTN | ISRCTN49676259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49676259 |
| Protocol serial number | 35915 |
| Sponsor | Croydon Health Services NHS Trust |
| Funders | NHS England, Alpha Laboratories Limited |
- 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
Plain English summary of protocol
Contact information
Scientific
Academic Colorectal Unit
Croydon University Hospital
Croydon
CR7 7YE
United Kingdom
 ORCID ID |
0000-0002-9614-6113 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Diagnosis, Device |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN49676259_PIS_V4.1_25May17.pdf |
| Scientific title | NICE Guidelines and the place of the Faecal Immunochemical Test as a triage tool for predicting Bowel Cancer |
| Study acronym | NICE FIT |
| Study objectives | 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(s) | London South East Research Ethics Committee REC,18/05/2017, ref: 16/LO/2174 |
| Health condition(s) or problem(s) studied | Colorectal Cancer |
| 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 |
| Primary outcome measure(s) |
1. Identify a suitable cut-off for the test |
| Key secondary outcome measure(s) |
1. Calculate the specificity, negative- and positive-predictive values for the chosen cutoff |
| Completion date | 01/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 6000 |
| Total final enrolment | 9822 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 31/03/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London Road
Thorton Heath
CR7 7YE
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
Middlesex
Uxbridge
UB8 3NN
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Kingston Upon Thames
KT2 7QB
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Guildford
GU2 7XX
United Kingdom
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Southampton
SO16 6YD
United Kingdom
Guildford Road
Chertsey
KT16 0PZ
United Kingdom
King's College Hospital NHS Foundation Trust
London
SE5 9RS
United Kingdom
Lewisham High Street
London
SE13 6LH
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
University NHS Foundation Trust
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Hampshire
Basingstoke
RG24 9NA
United Kingdom
4-6 Nuffield Road
Nuffield Industrial Estate Poole Dorset
Poole
BH17 0RB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/10/2020 | 23/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Patient survey substudy | 22/03/2022 | 18/01/2023 | Yes | No |
| Participant information sheet | version V4.1 | 25/05/2017 | 19/12/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
