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ObeSity Related Colorectal Adenoma Risk (OSCAR)

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ClinicalTrials.gov Identifier: NCT03663062
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
The Leeds Teaching Hospitals NHS Trust
Northumbria Healthcare NHS Foundation Trust
City Hospitals Sunderland NHS Foundation Trust
County Durham and Darlington NHS Foundation Trust
North Tees and Hartlepool NHS Foundation Trust
South Tees Hospitals NHS Foundation Trust
Kettering General Hospital NHS Foundation Trust
Information provided by (Responsible Party):
South Tyneside NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Colorectal Adenoma Colorectal Neoplasm Colorectal Cancer Obesity Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Liver Fibrosis Diagnostic Test: Colonoscopy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ObeSity Related Colorectal Adenoma Risk
Actual Study Start Date : December 27, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy


Intervention Details:
  • 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.
    Other Names:
    • Blood tests
    • Fibroscan
    • BMI measurement
    • Waist circumference measurement
    • Blood pressure
    • Past medical history, family history, medication history


Primary Outcome Measures :
  1. Development of risk model of colorectal adenomas and CRC [ Time Frame: 24 months from patient recruitment ]
    Development of a risk model for colorectal adenoma or CRC based upon risk factors identified


Secondary Outcome Measures :
  1. To assess the association of abnormal liver enzymes and colorectal adenomas or CRC [ Time Frame: 24 months from patient recruitment ]
    Number of patients with colorectal adenomas or CRC who have abnormal liver enzymes

  2. To assess the association of markers of obesity and colorectal adenomas or CRC [ Time Frame: 24 months from patient recruitment ]
    Number of patients with colorectal adenomas or CRC who are obese, as measured by BMI or waist circumference

  3. Association between FIB4 score and presence of colorectal adenomas or CRC [ Time Frame: 24 months from patient recruitment ]
    Number of patients with colorectal adenomas or CRC who have abnormal FIB4 score

  4. Association between abnormal Fibroscan reading and presence of colorectal adenomas or CRC [ Time Frame: 24 months from patient recruitment ]
    Number of patients with colorectal adenomas or CRC who have abnormal Fibroscan readings

  5. To assess the association between lifestyle risk factors and colorectal adenomas or CRC [ Time Frame: 24 months from patient recruitment ]
    Number of patients with colorectal adenomas or CRC who are smokers or have high alcohol intake



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient referred for colonoscopy matching the inclusion and exclusion criteria
Criteria

Inclusion Criteria:

  1. Aged 18 years and over
  2. Able to give informed consent
  3. Indications:

    1. Patients with positive faecal occult blood test (FOBt) referred for index colonoscopy as part of Bowel Cancer Screening Programme
    2. Colonoscopy conversion from Bowelscope
    3. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663062


Contacts
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Contact: Sara Koo, MBChB 0191 404 1000 ext 2899 sara.koo@stft.nhs.uk
Contact: Ingrid Emmerson 0191 404 1000 ext 4756 ingrid.emmerson@stft.nhs.uk

Locations
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United Kingdom
South Tyneside NHS Foundation Trust Recruiting
South Shields, Tyne And Wear, United Kingdom, NE34 0PL
Contact: Colin Rees       colin.rees@stft.nhs.uk   
County Durham and Darlington NHS Foundation Trust Not yet recruiting
Darlington, United Kingdom, DL3 6HX
Contact: John Silcock       johnsilcock@nhs.net   
Kettering General Hospitals NHS Foundation Trust Not yet recruiting
Kettering, United Kingdom, NN16 8UZ
Contact: Ajay Verma       ajay.verma@nhs.net   
The Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Mark Hull       M.A.Hull@leeds.ac.uk   
South Tees Hospitals NHS Foundation Trust Not yet recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: John Greenaway       John.Greenaway@stees.nhs.uk   
Northumbria Healthcare NHS Foundation Trust Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE12 8EW
Contact: Tom Lee, MD       Tom.Lee@northumbria-healthcare.nhs.uk   
Newcastle Upon Tyne NHS Foundation Trust Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Stuart McPherson       Stuart.McPherson@nuth.nhs.uk   
North Tees and Hartlepool NHS Foundation Trust Not yet recruiting
Stockton-on-Tees, United Kingdom, TS19 8PE
Contact: Matt Rutter       Matt.Rutter@nth.nhs.uk   
CIty Hospitals Sunderland NHS Foundation Trust Not yet recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Colin Rees       colin.rees@stft.nhs.uk   
Sponsors and Collaborators
South Tyneside NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
The Leeds Teaching Hospitals NHS Trust
Northumbria Healthcare NHS Foundation Trust
City Hospitals Sunderland NHS Foundation Trust
County Durham and Darlington NHS Foundation Trust
North Tees and Hartlepool NHS Foundation Trust
South Tees Hospitals NHS Foundation Trust
Kettering General Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Colin Rees, FRCP South Tyneside NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by South Tyneside NHS Foundation Trust:
Study Protocol  [PDF] October 24, 2017
Informed Consent Form  [PDF] July 14, 2017


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Responsible Party: South Tyneside NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03663062     History of Changes
Other Study ID Numbers: OSCAR
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans for this at present

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by South Tyneside NHS Foundation Trust:
colorectal adenoma
colorectal cancer
Obesity
Non-Alcoholic Fatty Liver Disease
Metabolic syndrome
Liver Fibrosis

Additional relevant MeSH terms:
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Metabolic Syndrome
Obesity
Colorectal Neoplasms
Fibrosis
Liver Diseases
Fatty Liver
Adenoma
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms, Glandular and Epithelial