Clinical trial NCT04185779: COLO-COHORT (Colorectal Cancer Cohort) Study
Official title: COLO-COHORT (Colorectal Cancer Cohort) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Adenoma
Colorectal Neoplasm
Predictive Cancer Model
Model
Lead sponsor: South Tyneside and Sunderland NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2019-12-04
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Occurrence of colorectal neoplasia
timeFrame: 5 years
Secondary outcomes:
measure: Stool microbiome pattern
timeFrame: 5 years
measure: Number of participants who consent for future contact
timeFrame: 5 years
Other outcomes:
Locations:
city: South Shields
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation Trust
state: Tyne And Wear
city: Kettering
country: United Kingdom
facility: Kettering General Hospitals NHS Foundation Trust
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees and Hartlepool NHS Foundation Trust
Study officials:
affiliation: Newcastle University
name: Colin Rees
role: PRINCIPAL_INVESTIGATOR
References: