Dataset Information

Reducing Colonoscopies in Patients Without Significant Bowel Disease

ABSTRACT: Investigating people with bowel symptoms uses a test that detects traces of blood in the stools, the FIT test. There are many possible reasons for positive tests. A few people have cancer. However, most participants with symptoms don’t have any serious bowel disease but have benign problems such as piles or irritable bowel syndrome (IBS). It is very difficult to diagnose on symptoms alone, those participants who have serious bowel disease and those who do not. After a positive test, people are invited for colonoscopy - a sort of articulated tube that is passed up the bowel. Most people invited for colonoscopy don’t have cancer. Only about 5% of those with positive FIT tests have cancer. About 25% have other bowel diseases, but most have nothing serious wrong at all. So they have the inconvenience and discomfort of colonoscopy but don’t get any benefit from it. The investigators want to try adding another test, the volatile organic compound (VOC) test, to see if the investigators can separate those with positive FIT tests who do have something wrong, from those who don’t. The VOC test uses a urine sample. Using both tests might also be better for detecting cancer. FIT alone misses about 20%. So the investigators think that using both tests might not only be better for detecting cancer, but also might mean that a lot of people will avoid having to have colonoscopy. This study will recruit 1,819 participants with bowel symptoms from NHS trusts in the UK. They will provide stool samples for FIT and urine for VOC analysis. They will have colonoscopy to get a definite diagnosis. Then the investigators will look at their FIT and VOC test results to see if in future, people with both tests negative.

DISEASE(S): Colorectal Disorders,Colorectal Adenoma,Colorectal Cancer,Adenoma,Colorectal Polyp,Oral And Gastrointestinal

PROVIDER: 2349096 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background and study aims Most bowel cancers develop from adenomas, a type of small growth that grows on the bowel wall. Removing adenomas can help to prevent the development of cancer. The NHS now offers screening for bowel cancer to all men and women aged between 60 and 69 years and from 2010, the age range will be extended to 74 years. The screening test, called FOBT, looks for traces of blood in the stool. People who have a positive FOBT are offered colonoscopy, an examination in which an endoscope is used to examine the lining of the bowel for cancers and polyps. Those who have large or multiple adenomas found at colonoscopy are known to have an increased risk of developing more adenomas and possibly bowel cancer. Therefore they are currently offered surveillance colonoscopy at 3 year intervals. There are a number of problems with this approach. Colonoscopy is a costly procedure requiring a skilled doctor, and it carries a small risk of serious complications. It can miss lesions - indeed most advanced lesions (large adenomas or cancers) found at follow-up examinations were present but missed at the previous colonoscopy. Surveillance colonoscopy is also wasteful of resources because significant lesions are found in only about 3% of examinations, so 97% of surveillance colonoscopies will find either nothing or only small harmless adenomas. This is reassuring to the patient but offers no real benefit. Because more adenomas are now being found as a result of the NHS Bowel Cancer Screening Programme (BCSP), the number of surveillance colonoscopies is increasing and threatens to overwhelm available resources. A more cost-effective way of protecting people with higher-risk adenomas is required. We propose that a new type of stool test (faecal immunological test, FIT) could offer effective protection for this higher-risk group at a fraction of the cost. Only patients who had a positive FIT result would need to be offered colonoscopy. This study is designed to estimate the benefit of this approach. Who can participate? People who have taken part in the Bowel Cancer Screening Programme (BCSP) and have been diagnosed with large or multiple adenomas What does the study involve? Participants are offered the FIT at 1, 2 and 3 years. The test is very simple, requiring participants to collect a tiny amount of stool on a probe and return to the laboratory (easier than the FOBT which requires 6 stool samples). Participants who have a positive FIT result are offered a colonoscopy immediately and their next colonoscopy will be three years later. Those who do not test positive to any of the three annual FITs have their colonoscopy at 3 years in the usual way. We compare the total number of bowel lesions found in people who test positive at the 1st, 2nd or 3rd FITs with the number of lesions found at 3-year colonoscopy in those who had a negative FIT result. If most important lesions are found in the group who have positive FIT results, this would suggests that this new approach could provide effective protection and ultimately mean that colonoscopy could be used only in cases with a positive FIT result.

Project description:Background and study aims Bowel cancer is a National Health Service (NHS) priority as 1 in 20 people will develop the disease and half of those will die, equating to 17,000 each year in the UK. Bowel cancer is largely preventable via the timely detection and removal of precancerous growths in the bowel (called adenomas) and chances of survival are improved greatly if bowel cancer is detected early, before the disease causes symptoms. As a result, screening tests for adenomas and bowel cancer in people who do not currently have symptoms are an important method for reducing the number of deaths from bowel cancer. However, the success of any screening test depends on people being willing to be tested so it is essential that tests are as acceptable as possible to invitees in order to maximise uptake. There are several tests that could be used to screen for bowel cancer, each with their own advantages and disadvantages, and there is no clearly superior option. For example, some tests are more accurate than others but screening invitees might consider these to be less convenient than alternatives. It is currently unclear which test people would be most likely to have. It is also uncertain what the specific reasons are that underpin these preferences. This study aims to answer these questions. Who can participate? We are recruiting members of the public who are representative of individuals who have not had bowel cancer screening before but are approaching the age at which it is offered. We are sending out questionnaires to men and women aged 45-54 years via their General Practitioner. We are also using several other criteria to ensure that people in our study are similar to those who would be offered screening. For example, individuals will only be invited to take part if they have not previously had a diagnosis of bowel cancer or already have regular bowel tests for reasons unrelated to screening. What does the study involve? People who are eligible to take part in the study will be posted a questionnaire and written information about one of the four tests that we are investigating. The test that they will receive information about will be randomly determined. Individuals will be asked to read the information and complete the questionnaire, which asks questions on whether they believe they would be willing to have the test and their impressions of the different aspects of the procedure (for example, how convenient or inconvenient it might be for them). Participants will then send the questionnaire back to the main study centre, where we will compare peoples responses across the different tests once they have all been collected.

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Reducing Colonoscopies in Patients Without Significant Bowel Disease

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