Findings from the largest international research study found that using FIT is almost 100% accurate at ruling out bowel cancer in patients with suspicious symptoms.
The study has just been published in Gut, and the research already won prestigious top prizes of the two main surgical societies in the UK.
The NICE FIT study was led by Croydon University Hospital, with Mr Muti Abulafi, Consultant Colorectal Surgeon at Croydon University Hospital, as Chief Investigator. It was supported by RM Partners, the West London Cancer Alliance hosted by The Royal Marsden with funding from NHS England's cancer transformation fund.
It was the largest international research study assessing the accuracy of using a faecal immunochemical test (FIT) in ruling out bowel cancer in patients with high-risk symptoms.
Results showed that a FIT test is effective at ruling out colorectal cancer with 99.8% accuracy whilst at the same reducing the need for invasive investigations and a visit to the hospital in approximately 60% of patients with a negative FIT result.
The aim of the study was to establish the diagnostic accuracy of FIT in symptomatic patients referred with suspected colorectal cancer under the current NICE guidelines
Recruitment began in October 2017, and when recruitment finished in April 2019, 25,000 patients from 55 hospital sites in England were invited to participate in the trial, and almost 10,000 patients with colonoscopy outcomes were included in the data analysis. The study was completed in January 2020.
The study has shown FIT to be as sensitive a test as colonoscopy, which is currently the gold standard for detection of colorectal cancer. The evidence generated from the study shows that FIT can potentially significantly reduce the number of colonoscopies undertaken, by identifying those who do not require the invasive test.
Further analysis of the dataset is being undertaken to examine the sensitivity of FIT at diagnosing other colorectal conditions.
Mr Muti Abulafi, Chief Investigator, said "NICE FIT is the largest diagnostic accuracy study ever performed of FIT in patients presenting with bowel symptoms. It proves that this simple, at home test is highly sensitive and can detect bowel cancer, when present, with 97% accuracy.'
'FIT will certainly revolutionise the way we manage patients with suspected bowel cancer symptoms. I cannot thank enough everyone who made this research a reality, above all the thousands of patients who volunteered to take part.'
Mr Nigel D'Souza, Colorectal Surgical Fellow, supported the NICE-FIT clinical trial during his research fellowship at Croydon University Hospital. He said: ''Our results show that FIT is essentially a very accurate home test for bowel cancer. If the test is negative in patients with symptoms, the chance of being cancer free is 99.8%. This test can be performed at home without needing to visit hospital or even your GP, which is particularly useful during this time of coronavirus. This study was unprecedented in its scale, and the results have undoubtedly transformed bowel cancer outcomes and care for patients with bowel symptoms in England."
Notes to editors:
- The NICE guidelines and Faecal Immunochemical Test (NICE FIT) study was a RM Partners-led, clinical trial that was carried out in response to a call for further evidence by NICE for the use of FIT in the high risk population in the UK in 2017.
- The research was funded by RM Partners, through the Cancer Transformation Fund from NHS England and was supported by the National Institute of Health Research (NIHR).
- Results showed that the FIT test is effective at ruling out colorectal cancer with 99.8% accuracy when used at a cut off at 10μg/g.
- During COVID, cancer diagnostics services were suspended and continue to be disrupted. Clinicians in London, along with NHS England, London region, agreed to rapidly implement the use of FIT in primary care in order to manage and triage patients with symptoms.
- Mr Nigel D'Souza was awarded the prestigious BJS Surgery Prize for his work on the NICE FIT clinical trial. The prize was awarded as part of The Association of Coloproctology of Great Britain and Ireland (ACPGI) annual conference. He also won the prestigious Moynihan Prize of the Association of Surgery of Great Britain and Ireland (ASGBI), the Association's most prestigious scientific award and joins a few select and elite surgeon members which date back to 1951.
- The full paper, Using the faecal immunochemical test to select patients with bowel cancer symptoms for investigation: a diagnostic accuracy study, is available here: https://gut.bmj.com/content/early/2020/10/06/gutjnl-2020-321956