Condition category
Cancer
Date applied
11/07/2019
Date assigned
23/12/2019
Last edited
04/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

https://www.colospeed.org

Contact information

Type

Scientific

Primary contact

Dr James Hampton

ORCID ID

Contact details

Research and Innovation Department
Old Child and Family Block
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom
+44 (0) 191 404 1000 ext 2899
James.Hampton@stft.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Colorectal Cancer Cohort Study (COLO-COHORT)

Acronym

COLO-COHORT

Study hypothesis

1. It is possible to identify factors (derived from socio-demographics, medical history, family history, lifestyle, FIT test results, blood test results) which successfully predict risk of colorectal neoplasia in individuals with symptoms attending for colonoscopy
2. It is possible to identify those individuals most likely to have advanced adenomas (adenomas ≥10mm, any villous component, presence of high-grade dysplasia) or CRC at surveillance colonoscopy
3. Individuals with and without colorectal neoplasia have distinct microbiome profiles
4. To develop a platform of patients who consent to future contact for future research studies (COLO-SPEED)

Ethics approval

Approved 20/06/2019, West Midlands - Edgbaston Research Ethics Committee (Royal College of Surgeons Edinburgh, Birmingham B3 2BB; 02071048036; NRESCommittee.WestMidlands-Edgbaston@nhs.net), ref: 19/WM/0193

Study design

Observational multicentre cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Colorectal neoplasia, colorectal cancer

Intervention

Group A (cross-sectional arm, 10,000 patients)
In 6,000 patients from this group, patients will be asked to submit a Faecal Immunochemical Test (FIT) sample and be asked to have blood tests taken including blood for DNA extraction. In the remaining patients, we will record recent blood results of interest. For all patients, we will obtain information on their past medical history, alcohol history, smoking history, family history, anthropometric measurements including waist circumference, and information from their colonoscopy and histology of polyps removed or biopsies taken.

COLO-SPEED, Group B:
Patients will be asked to consent to future contact for collection of additional information, contact for future research studies, use of samples or information from this study to be used in future research studies, for longitudinal follow up through medical notes or national databases, and use of information from previous lower gastrointestinal endoscopy and histology as well as laboratory results in future research studies.

Follow up for patients who consent for long term follow up will be 10 years post consent.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The occurrence of colorectal neoplasia (colorectal cancer and advanced adenomas), measured by reviewing patient endoscopy reports, blood results, and health questionnaire. These will be analysed via logistic regression and subsequent structural equation modelling. Timepoint: baseline

Secondary outcome measures

Stool microbiome in different patient subgroups (i.e., normal colon, adenomas, bowel cancer), measured by reviewing stool samples at baseline

Overall trial start date

01/10/2018

Overall trial end date

31/07/2034

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Group A:
1. Aged ≥30 years and able to give informed consent
2. Patients attending colonoscopy:
2.1 Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
2.2 Through standard NHS care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, planned polypectomy, those referred on basis of family history, abnormal cross-sectional imaging, polyp surveillance or post CRC surveillance)

(COLO-SPEED) Group B:
1. Any patient attending for colonoscopy and able to give informed consent
2. At least 18 years old
3. In a centre supported by COLO-SPEED infrastructure (i.e. in North of England)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15,000

Participant exclusion criteria

Group A:
1. Unable to give informed consent
2. Known polyposis syndrome
3. Previous total colectomy
4. Known colonic stricture which would limit complete colonoscopy
5. Attending for planned therapeutic procedure other than polypectomy, such as insertion of colonic stent
6. Attending for assessment of known inflammatory bowel disease (IBD) activity or for IBD surveillance
7. Patients currently recruited into an interventional CTIMP for CRC prevention

COLO-SPEED (Group B):
1. DOes not meet inclusion criteria

Recruitment start date

01/08/2019

Recruitment end date

31/08/2024

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom

Sponsor information

Organisation

South Tyneside and Sunderland NHS Foundation Trust

Sponsor details

South Tyneside District Hospital
South Shields
NE340PL
United Kingdom
+44 (0)191 4028194
claire.livingstone@stft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Guts UK Charity

Alternative name(s)

Guts UK

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

For academic and clinical dissemination, the results will be submitted for publication in high-impact international peer-reviewed journals and presented to scientific meetings.
For dissemination to patients and public, lay summaries will be prepared, posted on the study website, and further disseminated through the websites of the individual participating sites and charities.
In order to contribute to a significant beneficial impact on clinical practice, the risk model will need to be tested for effectiveness compared to standard clinical pathways in independent cohorts in the UK and abroad. In conjunction with COLO-SPEED the research team are collaborating closely with UK and international clinical and research networks and organisations including British Society of Gastroenterology, Association of Coloproctology GBI, UK Therapeutic Cancer Prevention Network, Netherland society of Gastroenterology and the European Society of GI Endoscopy. COLO-SPEED is also supported by NHS England, Public Health England, NHS BCSP, Scottish Cancer Taskforce, Northern Ireland Cancer Network, Scottish Cancer Prevention Network and the Wales Cancer lead. The collaboration of these professional, research and governmental organisations will ensure that the risk model developed by COLO-COHORT will be tested and implemented in a manner that has maximal impact upon clinical care.

IPD sharing statement
The study management group will develop guidelines and processes at which other researchers can access this data, and this will be subject to review and approval from the study management group and PPI representatives. The guidelines and process to this will be made available on the study website (colospeed.org which is being developed). Patients will have been able to consent to use of their information in future research studies, as such only data from those who have consented to this will be made available. The timelines at which the data will be available and for how long will be disclosed at a later date.

Intention to publish date

01/07/2025

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/09/2020: Contact details updated. 14/08/2019: Trial's existence confirmed by ethics committee.