Colorectal cancer cohort study (COLO-COHORT)
| ISRCTN | ISRCTN17473023 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17473023 |
| ClinicalTrials.gov (NCT) | NCT04185779 |
| Sponsor | South Tyneside and Sunderland NHS Foundation Trust |
| Funder | Guts UK Charity |
- Submission date
- 11/07/2019
- Registration date
- 23/12/2019
- Last edited
- 26/11/2025
- 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
Contact information
Mrs Amy Burns
Scientific
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 |
|---|---|
| amy.burns6@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational multicentre cross-sectional study |
| Secondary study design | Cross sectional study |
| 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(s) |
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 |
| Key secondary outcome measure(s) |
Stool microbiome in different patient subgroups (i.e., normal colon, adenomas, bowel cancer), measured by reviewing stool samples at baseline |
| Completion date | 14/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 30 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 15000 |
| 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
- United Kingdom
- England
Study participating centre
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
England
South Shields
NE34 0PL
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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 | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/11/2025: A link to a plain English summary on CRUK was added.
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.
