ObeSity Related Colorectal Adenoma Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,430
- 试验地点
- 12
- 主要终点
- Risk model of colorectal adenomas and CRC
研究概览
简要总结
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.
详细描述
Bowel cancer, or colorectal cancer (CRC), is the second most common cancer affecting both men and women in England. The majority of CRCs develop from a pre-cancerous type of growth in the bowel called an adenoma. Detecting and removing these adenomas is important in reducing CRC risk. A study which undertook a once-off camera examination of the left hand side of the bowel (flexible sigmoidoscopy), removing any adenomas, demonstrated a reduction in CRC by 23% and reduced mortality by 31%.
Although a single cause for adenomas is not known, several factors can predispose patients to adenomas, including; age, gender, family history, cigarette smoking and excess body weight (EBW).
Obesity is becoming an increasing problem in the UK, with approximately a quarter of adults classed as obese in England. Patients who are obese are at higher risk of having adenomas. Studies have shown that patients with EBW are more likely to have fatty disease of the liver (non-alcoholic fatty liver disease, NAFLD) by laying down fat in the liver. Studies in Asia have shown that patients with NAFLD are more likely to have adenomas, and that these are more likely to be in the right side of the bowel which is furthest from the anus (right colon). Although these studies have shown a link between NAFLD and adenomas, they have all used invasive or expensive markers of fatty liver disease. No study has correlated the link between liver enzymes (blood tests) and adenomas or by using scoring systems to determine the presence or absence of significant fatty liver disease. Furthermore, no Western studies have confirmed the link between NAFLD and adenomas, meaning it is unclear whether this link is only present in the Asian population.
Approximately 400,000 colonoscopies (camera examinations of the large bowel) are performed each year within the NHS for the investigation of gastrointestinal symptoms, including: altered bowel habit, rectal bleeding and low blood count. When polyps are found, patients often have a follow-up surveillance colonoscopy to check that no new adenomas have formed. The timing and need for surveillance is based only on the number and size of adenomas found and does not take into account any risk factors which the patient may have.
The NHS Bowel Cancer Screening Programme (BCSP) invites all individuals aged 60-74 to undertake a stool sample test which looks for blood, called faecal occult blood testing (FOBt), every two years. Those who have a positive FOBt are then invited for a colonoscopy. This programme is purely based on age and is not targeted. Another arm of the BCSP was introduced in 2013, where all individuals aged 55 are invited for a flexible sigmoidoscopy and removal of adenomas. Anyone who is felt to be high risk according to the number or size of adenomas then undergoes a colonoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Risk model of colorectal adenomas and CRC
时间窗: 24 months from patient recruitment
Risk prediction model
次要结局
- The incidence of colorectal adenomas or CRC in patients who are smokers or who have high alcohol intake(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 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)
