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| Name | Class |
|---|---|
| Newcastle University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Cross-sectional arm) | This group will comprise of 10,000 patients who have been referred for a colonoscopy. We will be collecting information on their past medical history, smoking history, alcohol history, medication history and family history in addition to their colonoscopy findings. In 6000 of these patients, they will have blood tests, Faecal Immunochemical Test (FIT) level, blood or saliva for DNA extraction and stool microbiome taken. In 4000 of these patients, we will record recent blood tests of interest and they will have no new samples taken. All 10000 patients will also either complete a food frequency questionnaire or endoscopy patient experience questionnaire. |
| |
| COLO-SPEED (Group B, consent for contact arm) | This will be 10,000 patients who will consent for future contact for future research studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Diagnostic Test | Diagnostic colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of colorectal neoplasia | Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Stool microbiome pattern | Assessing trends in variation of stool microbiome in patients with normal colon, adenomas, bowel cancer) | 5 years |
| Number of participants who consent for future contact |
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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)
(COLO-SPEED) Group B
Exclusion Criteria:
Group A
COLO-SPEED (Group B) **
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Patients who have been referred for a colonoscopy (minimum age limits as above in inclusion criteria) either through the bowel cancer screening programme, as part of a surveillance programme or due to symptoms
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Koo | Contact | 0191 404 1000 | sara.koo@stft.nhs.uk | |
| Amy Burns | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Colin Rees | Newcastle University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Tyneside and Sunderland NHS Foundation Trust | Recruiting | South Shields | Tyne and Wear | NE34 0PL | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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DNA extraction from blood, saliva and stool
A registry of patients who consent to be contacted in the future for future research studies
| 5 years |
| Kettering General Hospitals NHS Foundation Trust | Not yet recruiting | Kettering | NN16 8UZ | United Kingdom |
|
| North Tees and Hartlepool NHS Foundation Trust | Recruiting | Stockton-on-Tees | TS19 8PE | United Kingdom |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |