Identifying high-risk factors for colorectal cancer
COLO-COHORT (Colorectal Cancer Cohort) Study
This study is trying to find out what factors can help identify people at high risk for colorectal cancer so that doctors can improve screening methods for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | South Tyneside and Sunderland NHS Foundation Trust Academic / other |
| Locations | 3 sites (South Shields, Tyne and Wear and 2 other locations) |
| Trial ID | NCT04185779 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify factors that predict patients at high risk for colorectal cancer and adenomas, developing a risk prediction model based on these factors. It will involve a national multi-centre approach over five years, recruiting 10,000 patients undergoing colonoscopy either through the Bowel Cancer Screening Programme or due to symptoms. Participants will complete health questionnaires, undergo various tests, and provide samples for analysis. The study seeks to enhance screening criteria beyond age by incorporating additional risk factors.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 30 and older who are undergoing colonoscopy for various reasons, including screening or symptomatic evaluation.
Not a fit: Patients under 30 years old or those not undergoing colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening methods for colorectal cancer, potentially saving lives through earlier detection.
How similar studies have performed: Other studies have shown promise in using predictive models for cancer risk assessment, but this approach is novel in its comprehensive integration of multiple risk factors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
Group A
* Aged ≥30 years\* and able to give informed consent
* Patients attending colonoscopy
* Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
* 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)
* The age of 30 was chosen to ensure that this is a population likely to be enriched for colorectal neoplasia with neoplasia below this age uncommon \*\*In those attending for planned polypectomy, the results from the initial colonoscopy and the endoscopy where the polypectomy is undertaken will be summated for purposes of calculating the neoplasia profile
(COLO-SPEED) Group B
* Any patient attending for colonoscopy and able to give informed consent
* ≥ 18 years old
* Patient from the North of England
Exclusion Criteria:
Group A
* Unable to give informed consent
* Known polyposis syndrome
* Previous total colectomy
* Known colonic stricture which would limit complete colonoscopy
* Attending for planned therapeutic procedure other than polypectomy, such as insertion of colonic stent
* Attending for assessment of known inflammatory bowel disease (IBD) activity or for IBD surveillance
* Patients currently recruited into an interventional CTIMP for CRC prevention\*
COLO-SPEED (Group B) \*\*
* Unable to give informed consent
* Not in a centre supported by COLO-SPEED infrastructure (North of England)
Where this trial is running
South Shields, Tyne and Wear and 2 other locations
- South Tyneside and Sunderland NHS Foundation Trust — South Shields, Tyne and Wear, United Kingdom (Recruiting)
- Kettering General Hospitals NHS Foundation Trust — Kettering, United Kingdom (Not_yet_recruiting)
- North Tees and Hartlepool NHS Foundation Trust — Stockton-on-Tees, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Colin Rees — Newcastle University
- Study coordinator: Sara Koo
- Email: sara.koo@stft.nhs.uk
- Phone: 0191 404 1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.