A new test for ruling out colorectal cancer - The qFIT Pilot_v1

• Research type

  Research Study

• Full title

  A new test for ruling out colorectal cancer - The qFIT Pilot

• IRAS ID

  213710

• Contact name

  Michael R Machesney

• Contact email

  Michael.Machesney@bartshealth.nhs.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2016/12/55 , UCL Data Protection Registration

• Duration of Study in the UK

  0 years, 10 months, 17 days

• Research summary

  Th qFIT study is a six month pilot led by UCLH Cancer Collaborative. It will test the accuracy and process of the Quantitative Faecal Immunochemical Test (qFIT) with a minimum of 2000 patients within London. qFIT could be a cheap and reliable ‘rule’-out’ test of significant bowel disease and could help stem the increasing need for endoscopy resources.
  Colorectal cancer is UK's second biggest cancer killer but if diagnosed early enough there is more than a 90% chance of successful treatment. Last year, over 240,000 patients with lower abdominal symptoms were seen by a specialist following an urgent GP referral for suspected cancer. The majority of these patients were referred to colonoscopy but only about 4% of them will have cancer. There is growing evidence that qFIT test could rule out colorectal cancer in patients with lower abdominal symptoms. Two Scottish trials found that a normal qFIT showing no evidence of haemoglobin in stool may rule out the presence of colorectal cancer. If we demonstrate similar results in our population, we may be able to reduce the number of colonoscopies by approximately 40%, freeing up endoscopy capacity for other programmes such as bowel cancer screening.

  6 NHS Trusts and 33 GP practices who participate in the study will offer patients to take part in the pilot by completing a qFIT test as an addition to their normal 2 week wait(2ww) pathway. The qFIT test kit will be given out either (a) by their GP or (b) by the Endoscopy Unit staff at a participating Trust they are referred to. The patients will be asked to take a single sample at their next bowel movement and send the test to a dedicated lab via post. The qFIT test is then compared with the outcome of their colonoscopy.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  17/WM/0094

• Date of REC Opinion

  10 Mar 2017

• REC opinion

  Favourable Opinion