Condition category
Cancer
Date applied
21/01/2020
Date assigned
19/02/2020
Last edited
28/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The UK Bowel Cancer Screening Programme has reduced the risk of death from bowel cancer by 15%. People testing positive on a bowel cancer screening stool test are offered colonoscopy (bowel camera examination) through the UK Bowel Cancer Screening Programme. About half of those have cancers or polyps (small abnormal growths that might lead to cancer in the future) found on colonoscopy. There is some evidence to suggest that these cancers could be caused by a certain type of flat polyp called a serrated polyp which can be difficult to detect during standard colonoscopy. Small studies have suggested that these polyps and may grow into cancer faster than the usual polyps and up to 1 in 5 bowel cancers may actually have developed from these subtle serrated polyps. Moreover, deaths from cancer of the upper bowel are not reducing.
This study will investigate if spraying a blue dye in the upper large bowel helps the doctor to detect more flat polyps during the colonoscopy. At the moment it is not known if spraying the dye in the upper large bowel is the best way to improve detection so participants who are due to have a screening colonoscopy will be randomly assigned into two groups; one to have a standard colonoscopy and the other to have a colonoscopy using the dye spray. This will allow a comparison of what happens between the two groups. The aim is to find out through this study if this method works in practice and improves the detection and removal of more serrated polyps within the screening programme.

Who can participate?
All participants in the UK bowel screening programmes (Wales, England, Scotland) who test positive on the FIT test (bowel cancer screening stool test) and are eligible for an index screening colonoscopy. Participants will only be ineligible for the study if they have received previous resectional colorectal surgery (as this would influence both study methods and outcomes depending on the length of residual colon in the individual), and/or have a known allergy to food colouring agent (as the Indigo Carmine dye is a safe food colouring agent but extremely rarely there may be individuals with a specific allergic response to this in the past).

What does the study involve?
Participants are randomly allocated into two groups; one to have a standard colonoscopy and the other to have a colonoscopy using the dye spray. They are followed up through routinely collected data systems/

What are the possible benefits and risks of participating?
By participating in bowel screening, all participants will already have taken steps to detect polyps and consequently reduce their risk for future bowel cancer. If allocated to the dye spray group, more polyps may be detected and removed that could have turned into cancer, which further minimises the risk of future bowel cancer. However, the colonoscopy with dye spray will take on average 6 minutes longer than usual, especially if extra polyps are found, and there may be an increased risk of complications (e.g. bleeding if polyps found are removed) although we believe this to be very unlikely. Additionally, there is the chance that the extra polyps remove may never have turned into cancer.
For all participants, the main benefits of the study will be to inform UK bowel cancer screening programmes in the future as to whether the using dye spray during colonoscopies helps in the detection of serrated polyps and possibly prevention of bowel cancers.
The blue dye used within the interventional arm is a safe food colouring agent and is already used routinely in various endoscopy procedures in standard clinical practice. Extremely rarely there may be individuals with a specific allergic response to this in the past. For this reason, anyone with a known allergy to a food colouring agent will be excluded from taking part in the study.

Where is the study run from?
The trial team are based in the Centre for Trials Research (CTR) at Cardiff University. Overall, the researchers plan that 25 centres in total across Wales, England and Scotland will participate in the recruitment for the trial. The lead centre will be Llandough Hospital (Cardiff & Vale University Health Board) as this is the site that the Chief Investigator, Dr Sunil Dolwani, is based at.

When is the study starting and how long is it expected to run for?
June 2019 to December 2025

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Georgina Gardner
CONSCOP2@cardiff.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Georgina Gardner

ORCID ID

Contact details

Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
6th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)2920 687 950
CONSCOP2@cardiff.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

SPON 1781-19, CPMS 44738, IRAS 271876

Study information

Scientific title

Randomised controlled trial of contrast-enhanced colonoscopy in the reduction of right-sided bowel cancer (the CONSCOP 2 study)

Acronym

CONSCOP 2

Study hypothesis

Primary hypothesis:
1. Proximal advanced serrated lesion (SL) detection rates will be greater when spraying blue indigo carmine dye throughout the upper large bowel during colonoscopy (chromocolonoscopy) when compared to a standard colonoscopy without dye

Secondary hypotheses:
1. Other lesion detection rates (e.g. advanced neoplasia, serrated lesions, advanced adenomas) will be greater using chromocolonoscopy when compared to standard colonoscopy
2. Faecal immunochemical test (FIT) thresholds will impact on the SL detection rates in each arm of the study

Secondary objectives:
1. Evaluate the longer-term economic impact of chromocolonoscopy within the screening setting
2. Model and compare the post-colonoscopy interval advanced polyp and cancer detection and death rates for the two arms
3. Assess the association between demographic and lifestyle factors and SLs at index colonoscopy
4. Assess the association between demographic and lifestyle factors and SLs at surveillance colonoscopies in order to inform the stratification and optimisation of surveillance frequency

Ethics approval

Approved 26/02/2020, Wales REC6 (Meeting Room, Level 2, Wales National Pool, Sketty Lane, Swansea SA2 8QG, UK; +44 (0)1874 615949; Wales.REC6@wales.nhs.uk), ref: 20/WA/0019

Study design

Multicentre open-label individually randomised (1:1) controlled trial

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 to request a participant information sheet

Condition

Bowel cancer

Intervention

A randomised open controlled trial (RCT) of chromocolonoscopy (spraying blue indigo carmine dye throughout the upper large bowel during colonoscopy) vs a standard colonoscopy without dye in index bowel cancer screening to reduce bowel cancer mortality. CONSCOP2 will recruit 2652 participants from ~20 centres in England, Wales and Scotland attending index colonoscopies within the bowel screening programme and will follow them up through routinely collected data systems. The data obtained in this study will establish whether or not chromocolonoscopy should be used instead of standard white light for index colonoscopies within the UK bowel cancer screening programmes.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Detection of any proximal advanced serrated lesions as defined by pathological assessment at index colonoscopy (colonoscopy intervention)

Secondary outcome measures

1. Pathological types and counts of all polyps detected at index procedure (colonoscopy intervention)
2. Pathological types and counts of all polyps detected at surveillance procedure (up to 1 year after repeat procedures). Types of all polyps detected at surveillance procedures will be obtained from local histopathology reports and routinely collected screening datasets
3. Cancers and deaths obtained from routinely collected health datasets (follow up for 3 years)

Overall trial start date

18/06/2019

Overall trial end date

01/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All FIT-positive people in the participating centres, eligible for index screening colonoscopy using high definition scopes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2652

Participant exclusion criteria

1. Previous resectional colorectal surgery (as this would influence both study methods and outcomes depending on the length of residual colon in the individual)
2. Known allergy to food colouring agent (as the Indigo Carmine dye is a safe food colouring agent but extremely rarely there may be individuals with a specific allergic response to this in the past)

Recruitment start date

01/05/2020

Recruitment end date

01/09/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Betsi Cadwaladr University LHB
Executive Offices, Ysbyty Gwynedd Penrhosgarnedd Bangor Gwynedd
Bangor
LL57 2PW
United Kingdom

Trial participating centre

Hywel Dda University LHB
Corporate Offices, Ystwyth Building Hafan Derwen St Davids Park, Jobswell Road
Carmarthen
SA31 3BB
United Kingdom

Trial participating centre

Abertawe Bro Morgannwg University LHB
One Talbot Gateway, Seaway Drive Seaway Parade Industrial Estate Baglan
Port Talbot
SA12 7BR
United Kingdom

Trial participating centre

Cardiff & Vale University LHB
Corporate Headquarters Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Cwm Taf University LHB
Cwm Taf University LHB Dewi Sant Hospital Albert Road
Pontypridd
CF37 1LB
United Kingdom

Trial participating centre

Aneurin Bevan University LHB
Headquarters - St Cadoc's Hospital Lodge Road Caerleon
Newport
NP18 3XQ
United Kingdom

Trial participating centre

North Tees and Hartlepool NHS Foundation Trust
University Hospital Of Hartlepool Holdforth Road
Hartlepool
TS24 9AH
United Kingdom

Trial participating centre

NHS Tayside
Ninewells Hospital and Medical School James Arrott Drive
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospitals NHS Trust
Royal Liverpool University Hospital Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

Powys Teaching LHB
Glasbury House Bronllys Hospital
Brecon
LD3 0LS
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Nhs Greater Glasgow and Clyde
J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Trial participating centre

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

Trial participating centre

University Hospitals Of Leicester
Leicester Royal Infirmary Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

County Durham and Darlington NHS Trust
Bishop Auckland Hospital Cockton Hill Rd
Bishop Auckland
DL14 6AD
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

Research Governance Coordinator Research and Innovation Services Cardiff University
7th Floor
McKenzie House
30-36 Newport Rd
Cardiff
CF24 0DE
United Kingdom
+44 (0)29208 79130
ShawC3@cardiff.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Data from all sites will be analysed together and published as soon as possible. Individual participating PIs may not publish data concerning their participants that are directly relevant to questions posed by the trial until the TMG has published its report. The TMG will form the basis of the writing committee and advise on the nature of publications, subject to the Sponsor’s requirements. Publication will be according to the publication policy of the CTR and the CONSCOP2 publication plan.
Principles regarding authorship and writing:
1. All proposals for publications using CONSCOP2 data must be approved by the TMG
2. A lead author and wider writing team will be established for each identified paper
3. All potential contributors will have the opportunity to opt into a writing team
4. It is the responsibility of the Chief Investigator (CI) and Study Lead to ensure balance and inclusivity in writing teams across the range of likely study publications, to ensure everyone is appropriately acknowledged and has the opportunity to be involved as an author
5. It is the responsibility of the CI to decide authorship order, usually in discussion with the lead author and Study Lead
6. All named authors must meet authorship criteria (e.g. see http://www.bmj.com/about-bmj/resources-authors/article-submission/authorship-contributorshipauthorship))
7. Submission of abstracts for conference presentation should be agreed in advance with the TMG. Authors should allow sufficient time for their request to be reviewed. This may be completed via email. However, if there is insufficient time for the TMG to review such a request, the CI can make a decision on behalf of the TMG. The body of the presentation (including posters) should be reviewed by the TMG prior to presentation. This may be completed via email

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available on request upon consideration by the TSC and TMG. When enrolling for the trial, participants will provide their permission for the Sponsor (Cardiff University) to access their medical records through routinely collected cancer registries and national screening programmes. This will be used to follow up the health status of all participants. Participants will not be identified in any report, publication or presentation; all results will be completely anonymous.

Intention to publish date

01/09/2025

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/07/2020: The ethics approval was added. 17/02/2020: Trial's existence confirmed by the NIHR.