Colorectal cancer cohort study (COLO-COHORT)

ISRCTN	ISRCTN17473023
DOI	https://doi.org/10.1186/ISRCTN17473023
ClinicalTrials.gov number	NCT04185779

Submission date: 11/07/2019
Registration date: 23/12/2019
Last edited: 25/04/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mrs Amy Burns
Scientific

Research and Innovation Department
Old Child and Family Block
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom

Phone	+44 (0)191 404 1000 ext 2237
Email	amy.burns6@nhs.net

Study information

Study design	Observational multicentre cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Colorectal Cancer Cohort Study (COLO-COHORT)
Study acronym	COLO-COHORT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2018
Completion date	14/01/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	30 Years
Sex	Both
Target number of participants	15,000
Key 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)
Key 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
Date of first enrolment	01/08/2019
Date of final enrolment	14/01/2026

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

South Tyneside District Hospital

Harton Lane
South Shields
NE34 0PL
United Kingdom

Sponsor information

South Tyneside and Sunderland NHS Foundation Trust
Hospital/treatment centre

South Tyneside District Hospital
South Shields
NE34 0PL
England
United Kingdom

Phone	+44 (0)191 4028194
Email	claire.livingstone5@nhs.net
"ROR"	https://ror.org/044j2cm68

Funders

Funder type

Charity

Guts UK Charity
Private sector organisation / Other non-profit organizations

Alternative name(s): Guts UK
Location: United Kingdom

Results and Publications

Intention to publish date	14/01/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

25/04/2025: The overall study end date was changed from 14/01/2036 to 14/01/2026.
04/09/2024: The following changes were made to the study record:
1. Contact and sponsor details updated.
2. The recruitment end date was changed from 31/08/2024 to 14/01/2026.
3. The overall study end date was changed from 31/07/2034 to 14/01/2036.
4. The intention to publish date was changed from 01/07/2025 to 14/01/2027.
08/04/2024: ClinicalTrials.gov number added.
13/06/2023: Internal review.
04/09/2020: Contact details updated.
14/08/2019: Trial's existence confirmed by ethics committee.