At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Colonoscopy (diagnostic test)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- Colonoscopy — diagnostic test: Diagnostic colonoscopy
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 15,000
- Started
- 2019-12-13
- Last checked
- 2020-06
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal cancer
- • Clinical study - 15,000 participants
- • This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colorectal cancer
Where?
- • South Shields - South Tyneside and Sunderland NHS Foundation Trust
- • Kettering - Kettering General Hospitals NHS Foundation Trust
- • Stockton-on-Tees - North Tees and Hartlepool NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model.
More detail
Bowel cancer is the second commonest cause of cancer death in the UK with 16000 people dying per year. Although the NHS Bowel Cancer Screening Programme (BCSP) detects cancers at an earlier stage only 10% of all cancers are detected through screening. Currently, the only criteria for screening is age and no account is taken of other known risk factors such as smoking, alcohol, family history or obesity. Stool FIT (a new stool test which detects blood that can't be seen with the naked eye) will be introduced into the English BCSP, but there is poor evidence for its use in patients presenting with symptoms. There is also emerging data that there may be differences in the gut bacteria of people with and without cancer or pre cancerous bowel polyps (adenomas). This will be a national multi-centre study over 5-years. 10000 Patients undergoing colonoscopy as part of BCSP or due to symptoms will be recruited. Patients will be asked to fill in a health questionnaire, have their height, weight, waist circumference measured. Patients will also receive blood tests, stool tests or saliva tests depending on the indication for their colonoscopy. The results of the colonoscopy and any samples taken will be collated. Patients will receive a patient experience questionnaire or food frequency questionnaire. A further 10,000 patients from the North of England will be consented to be contacted for future studies with some of the information above collected. The aim of this study is to develop a risk prediction model to help determine which patients are at highest risk of having adenomas or bowel cancer. The investigators will also explore the significance of the gut bacteria composition in patients with adenomas or cancer to help inform this risk model. Additionally the investigators will develop a large platform of patients who consent to be contacted for future research.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Group A
- ✓Aged ≥30 years\* and able to give agreement to take part
- ✓Patients attending colonoscopy
- ✓Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
- ✓(COLO-SPEED) Group B
Who cannot take part
- ✗Group A
- ✗Unable to give agreement to take part
- ✗Known polyposis syndrome
- ✗Previous total colectomy
- ✗Known colonic stricture which would limit complete colonoscopy
See the full criteria
Where Is This Study? (3 UK sites)
South Tyneside and Sunderland NHS Foundation Trust
South Shields NE34 0PL, United Kingdom
Kettering General Hospitals NHS Foundation Trust
Kettering NN16 8UZ, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees TS19 8PE, United Kingdom
How to Get in Touch
Sara Koo
Sponsor contactCONTACT
Amy Burns
Sponsor contactCONTACT
