COLO-COHORT (Colorectal Cancer Cohort) Study

NCT04185779 | Recruiting

• 1 other identifier: 1
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Cancer; Colorectal Adenoma; Colorectal Neoplasm; Predictive Cancer Model; Model

Outcome Measures

Primary Outcomes (1)

• Occurrence of colorectal neoplasia

  Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas)

  5 years

Secondary Outcomes (2)

• Stool microbiome pattern

  5 years

• Number of participants who consent for future contact

  5 years

Study Arms (2)

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

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

Interventions

Colonoscopy DIAGNOSTIC_TEST

Diagnostic colonoscopy

COLO-SPEED (Group B, consent for contact arm); Group A (Cross-sectional arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead
• Newcastle University: collaborator

Study Sites (3)

South Tyneside and Sunderland NHS Foundation Trust

South Shields, Tyne and Wear, NE34 0PL, United Kingdom

RECRUITING

Kettering General Hospitals NHS Foundation Trust

Kettering, NN16 8UZ, United Kingdom

NOT YET RECRUITING

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, TS19 8PE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA extraction from blood, saliva and stool

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Colin Rees

  Newcastle University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Koo

CONTACT

0191 404 1000; sara.koo@stft.nhs.uk

Amy Burns

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: December 4, 2019
• Study Start: December 13, 2019
• Primary Completion: August 15, 2024
• Study Completion (Estimated): August 15, 2026
• Last Updated: October 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)