ObeSity Related Colorectal Adenoma Risk

NCT03663062 | Completed

• 1 other identifier: OSCAR
• Study Type: observational
• Target: 1,430
• Locations: 1 country
• Sites: 12

Brief 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

Keywords

colorectal adenoma; colorectal cancer; Obesity; Non-Alcoholic Fatty Liver Disease; Metabolic syndrome; Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• Risk model of colorectal adenomas and CRC

  Risk prediction model

  24 months from patient recruitment

Secondary Outcomes (5)

• The incidence of colorectal adenomas or CRC in patients with abnormal liver enzymes

  24 months from patient recruitment

• The incidence colorectal adenomas or CRC in patients with obesity

  24 months from patient recruitment

• The incidence colorectal adenomas or CRC in patients with abnormal FIB4 score

  24 months from patient recruitment

• The incidence colorectal adenomas or CRC in patients with abnormal Fibroscan readings

  24 months from patient recruitment

• The incidence of colorectal adenomas or CRC in patients who are smokers or who have high alcohol intake

  24 months from patient recruitment

Interventions

Colonoscopy DIAGNOSTIC_TEST

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.

Also known as: Blood tests, Fibroscan, BMI measurement, Waist circumference measurement, Blood pressure, Past medical history, family history, medication history

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

Any patient referred for colonoscopy matching the inclusion and exclusion criteria

You may qualify if:

• Aged 18 years and over
• Able to give informed consent
• Indications:
• Patients with positive faecal occult blood test (FOBt) referred for index colonoscopy as part of Bowel Cancer Screening Programme
• Colonoscopy conversion from Bowelscope
• Index diagnostic colonoscopy due to new gastrointestinal symptoms (including but not restricted to diarrhoea, change in bowel habit, abdominal pain, PR bleeding, weight loss), iron deficiency anaemia, family history of CRC, abnormal findings on cross sectional imaging

You may not qualify if:

• Absolute contraindication to colonoscopy
• Unable to give informed consent
• Known colorectal cancer
• Known polyposis syndrome
• Previous total/subtotal colectomy
• Known colonic stricture which would prevent completion of colonoscopy
• Attending for therapeutic procedure
• Attending for assessment of a known lesion
• Attending for assessment of known inflammatory bowel disease (IBD)
• Attending for surveillance colonoscopy (polyp surveillance, post colorectal cancer surveillance, IBD surveillance)
• Colonoscopy within the last 5 years

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• City Hospitals Sunderland NHS Foundation Trust: collaborator
• North Tees and Hartlepool NHS Foundation Trust: collaborator
• South Tees Hospitals NHS Foundation Trust: collaborator
• Kettering General Hospital NHS Foundation Trust: collaborator
• Royal Bolton Hospital NHS Foundation Trust: collaborator
• Gloucestershire Hospitals NHS Foundation Trust: collaborator
• University Hospitals of Morecambe Bay NHS Trust: collaborator
• Mid Cheshire Hospitals NHS Foundation Trust: collaborator
• Lancashire Teaching Hospitals NHS Foundation Trust: collaborator
• Blackpool Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (12)

Royal Bolton Hospital

Bolton, Greater Manchaster, BL4 0JR, United Kingdom

Location

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, Lancashire, LA1 4RP, United Kingdom

Location

Mid Cheshire Hospitals NHS Foundation Trust

Crewe, Mid Cheshire, CW1 4QJ, United Kingdom

Location

South Tyneside NHS Foundation Trust

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

Location

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, GL1 3NN, United Kingdom

Location

Kettering General Hospitals NHS Foundation Trust

Kettering, NN16 8UZ, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Newcastle Upon Tyne NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, PR25BW, United Kingdom

Location

North Tees and Hartlepool NHS Foundation Trust

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

Location

CIty Hospitals Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Obesity; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Interventions

Colonoscopy; Hematologic Tests; Blood Pressure; Medical History Taking

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Fatty Liver; Liver Diseases; Fibrosis; Pathologic Processes

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; Clinical Laboratory Techniques; Investigative Techniques; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Colin Rees, FRCP

  South Tyneside and Sunderland NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: September 10, 2018
• Study Start: December 27, 2017
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: November 4, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)