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 fecal 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.
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 revolutionize 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 Muti Abulafi, Chief Investigator
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."
D'Souza, N., et al. (2020) Faecal immunochemical test is superior to symptoms in predicting pathology in patients with suspected colorectal cancer symptoms referred on a 2WW pathway: a diagnostic accuracy study. Gut. doi.org/10.1136/gutjnl-2020-321956.