Actively Recruiting
COLO-COHORT (Colorectal Cancer Cohort) Study
Led by South Tyneside and Sunderland NHS Foundation Trust · Updated on 2020-10-22
15000
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
South Tyneside and Sunderland NHS Foundation Trust
Lead Sponsor
N
Newcastle University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying colorectal cancer and colorectal adenomas to identify factors that best predict patients at high risk and to develop a risk prediction model. This observational study is national and multi-centre, focusing on patients undergoing colonoscopy either as part of the Bowel Cancer Screening Programme or due to symptoms. It addresses the limitation that current screening mainly considers age and aims to include other risk factors like smoking, alcohol use, family history, obesity, and gut bacteria composition. Participants will be divided into two groups: one group of 10,000 patients referred for colonoscopy will provide detailed health and lifestyle information, including blood, stool, and saliva samples for various tests. Another group of 10,000 patients from the North of England will consent to be contacted for future research studies, providing some health information for this purpose. The study collects data on colonoscopy results, lifestyle factors, and patient experiences through questionnaires. During the study, patients will undergo measurements such as height, weight, and waist circumference, and complete health and food frequency questionnaires. Researchers will analyze colonoscopy findings, stool microbiome patterns, and biological samples to develop a risk prediction model for colorectal neoplasia. The study also aims to establish a platform of patients willing to participate in future research, with all results and patient consents tracked over a five-year period.
CONDITIONS
Brief Title
COLO-COHORT (Colorectal Cancer Cohort) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Group A: Aged 30 years or older and able to give informed consent
- Attending colonoscopy through the Bowel Cancer Screening Programme or standard NHS care
- Group B (COLO-SPEED): Any patient aged 18 years or older attending colonoscopy and able to give informed consent
- Group B: Patient from the North of England consenting to future contact for research
You will not qualify if you...
- Unable to give informed consent
- Known polyposis syndrome
- Previous total colectomy
- Known colonic stricture limiting complete colonoscopy
- Attending for planned therapeutic procedure other than polypectomy
- Attending for assessment or surveillance of known inflammatory bowel disease
- Currently recruited into an interventional clinical trial for colorectal cancer prevention
- Not in a centre supported by COLO-SPEED infrastructure (for Group B)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of colonoscopy
Participants undergo a colonoscopy and provide health questionnaires and biological samples as part of the diagnostic assessment.
1 visit (in-person)
Duration - Up to 5 years
Participants are followed up for up to 5 years to observe colorectal neoplasia occurrence and stool microbiome patterns.
Follow-up contact for questionnaires and data collection
Trial Site Locations
Total: 3 locations
1
South Tyneside and Sunderland NHS Foundation Trust
South Shields, Tyne and Wear, United Kingdom, NE34 0PL
Actively Recruiting
2
Kettering General Hospitals NHS Foundation Trust
Kettering, United Kingdom, NN16 8UZ
Not Yet Recruiting
3
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
Research Team
S
Sara Koo
A
Amy Burns
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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