COLO-COHORT (Colorectal Cancer Cohort) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Neoplasm; Colorectal Adenoma; Predictive Cancer Model; Model
• Intervention / Treatment: Diagnostic test: Colonoscopy

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.

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Sara Koo; Phone Number: 0191 404 1000; Email: sara.koo@stft.nhs.uk
• Study Contact Backup: Name: Amy Burns

Study Locations

• United Kingdom
  • Kettering, United Kingdom, NN16 8UZ
    • Not yet recruiting
    • Kettering General Hospitals NHS Foundation Trust
    • Contact: Ajay Verma; Email: ajay.verma@nhs.net
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Recruiting
    • North Tees and Hartlepool NHS Foundation Trust
    • Contact: Roisin Bevan; Email: Roisin.Bevan@nth.nhs.uk
  • Tyne And Wear
    • South Shields, Tyne And Wear, United Kingdom, NE34 0PL
      • Recruiting
      • South Tyneside and Sunderland NHS Foundation Trust
      • Contact: Colin Rees; Email: colin.rees@stft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Colonoscopy; Diagnostic colonoscopy
COLO-SPEED (Group B, consent for contact arm); This will be 10,000 patients who will consent for future contact for future research studies.	Diagnostic test: Colonoscopy; Diagnostic colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of colorectal neoplasia	Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas)	5 years

Secondary Outcome Measures

Outcome Measure	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	A registry of patients who consent to be contacted in the future for future research studies	5 years

Collaborators and Investigators

• Sponsor: South Tyneside and Sunderland NHS Foundation Trust
• Collaborators: Newcastle University
• Investigators: Principal Investigator: Colin Rees, Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Anticipated): August 15, 2024
• Study Completion (Anticipated): August 15, 2026

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No