ObeSity Related Colorectal Adenoma Risk

NCT03663062 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1430

Last updated 2020-11-04

No results posted yet for this study

Summary

In the UK, around 1 in 16 men and 1 in 20 women will develop bowel cancer at some point in their lives. Most bowel cancers happen when a type of growth in the bowel called an adenoma eventually becomes cancerous. Cutting out adenomas reduces the risk of developing bowel cancer.

Certain people are more likely to have adenomas than others, for example people who are overweight. People who are overweight are also more likely to develop liver disease by laying too much fat down in the liver. Studies in Asia have shown that people with fatty liver disease are more likely to have adenomas and these are more commonly found in the part of the bowel (right colon) furthest from the bottom end.

Information on the link between obesity, fatty liver disease and adenomas is very limited, particularly in the Western population.

The investigators will assess the link between body weight, fatty liver and adenomas in the UK population. 1430 patients will be invited; some through the bowel cancer screening programme and some with symptoms such as low blood count, bleeding or changed bowel habit. These patients will already have been referred for a camera test looking into the bowel, called a colonoscopy. Information including height, weight and some health questions will be taken. Blood samples will be taken. The investigators will compare the number of patients with adenomas who have liver disease or who are overweight with those who don't. This information will be used to develop a scoring system to predict risk of adenomas. This will help the investigators to decide if undertaking colonoscopies in these patients will identify those at increased risk of bowel cancer.

Conditions

  • Colorectal Adenoma
  • Colorectal Neoplasm
  • Colorectal Cancer
  • Obesity
  • Metabolic Syndrome
  • Non-Alcoholic Fatty Liver Disease
  • Liver Fibrosis

Interventions

DIAGNOSTIC_TEST

Colonoscopy

All patients would undergo colonoscopy as part of standard care. Patients recruited for this study would have their past medical history, family history, medication history, as well as waist circumference, BMI and blood pressure recorded. All patients would also have blood tests (described earlier) and a subset will undergo Fibroscan.

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER
  • City Hospitals Sunderland NHS Foundation Trust

    collaborator OTHER
  • North Tees and Hartlepool NHS Foundation Trust

    collaborator OTHER
  • South Tees Hospitals NHS Foundation Trust

    collaborator OTHER
  • Kettering General Hospital NHS Foundation Trust

    collaborator OTHER
  • Royal Bolton Hospital NHS Foundation Trust

    collaborator OTHER
  • Gloucestershire Hospitals NHS Foundation Trust

    collaborator OTHER
  • University Hospitals of Morecambe Bay NHS Trust

    collaborator OTHER
  • Mid Cheshire Hospitals NHS Foundation Trust

    collaborator OTHER_GOV
  • Lancashire Teaching Hospitals NHS Foundation Trust

    collaborator OTHER
  • Blackpool Teaching Hospitals NHS Foundation Trust

    collaborator OTHER
  • South Tyneside and Sunderland NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Colin Rees, FRCP · South Tyneside and Sunderland NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2019-06-07
Completion
2019-06-07

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03663062 on ClinicalTrials.gov