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Piloting the qFIT test for patients with lower abdominal symptoms in London Background Colorectal cancer is the fourth most common cancer registered in England and UK's second biggest cancer killer but if diagnosed early enough there's more than a 90% chance of successful treatment.1 Last year, over 240,000 patients2 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 trials3 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. Aim of the pilot This 6 month qFIT pilot study led by UCLH Cancer Vanguard will test the accuracy and process of the qFIT test with over 2000 patients (recruited through participating GP practices or participating Trusts) in London. The qFIT test could help stem the increasing need for endoscopy resources and will support the NG12 NICE guidelines for colorectal cancer offering a cheap and reliable test as a decision tool for colorectal investigation. Method for the pilot 1. Up to 5 NHS Trusts and 15+ GP practices who ideally have 5-10/month two-week wait referrals for suspected lower GI cancers in London will participate in the study. 2. The study will initially run from November 2016 for 6 months. 3. Patients with lower GI symptoms will be invited to take the qFIT test as part of their 2ww referral pathway. The test will be given out by participating GPs and participating Trusts. For participating GPs 4. A template will be created in the GP practice’s electronic patient record system to capture basic patient identifable data before the pilot starts. 5. The GP makes a referral for patient with lower GI symptoms and at the same time gives the qFIT test kit to the patient. The kit contains a sample collection tube (see image), instructions, patient information sheet, patient data sheet and pre-labelled return envelope. 1 Lansdorp-Vogelaar I, van Ballegooijen M, Zauber AG, Habbema JD, Kuipers EJ. Effect of rising chemotherapy costs on the cost savings of colorectal cancer screening. 2 NHS England. Waiting Times for Suspected and Diagnosed Cancer Patients 2014-15 Annual Report 3 Mowat C, Digby J, Strachan JA, Wilson R, Carey FA, Fraser CG, Steele RJ. Faecal haemoglobin and faecal calprotectin as indicators of bowel disease in patients presenting to primary care with bowel symptoms. Gut. 2015 Aug 20. pii: gutjnl-2015309579. doi: 10.1136/gutjnl-2015-309579. and Godber IM, Todd LM, Fraser CG, MacDonald LR, Younes HB. Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms. Clin Chem Lab Med. 2016 Apr;54(4):595-602. doi: 10.1515/cclm2015-0617. The GP is requested to print the pilot’s patient data sheet from the patient’s electronic record from a pre-filled form and add the name of the trust the patient is referred to. The form is then place in the qFIT test kit that the patient takes home. 6. The GP will be asked to record basic information (age-range, sex, and ethnicity) of eligible patients who they offered the qFIT test kit on a paper form. This would allow monitoring test uptake. 7. The patient will be asked to take a single sample at their next bowel movement and send the test to a dedicated lab via post. 8. Faecal haemoglobin concentrations are measured on a sample. 9. Test outcomes will be entered into a secure database hosted at UCLH. The database holds a record for each study participant who is identified primarily by his NHS number. 10. The pilot will also collect the data on the colonoscopy outcome. 11. Patient will not be notified about qFIT test outcome. Participating Trusts and GPs will get feedback on qFIT pilot at the end of the study. 12. The pilot will assess if qFIT can be used as per the guidelines for a stool test proposed in NICE Guideline (NG12). Support provided for GP practices Set up the data information sheet template in the practice’s electronic patient record systems A qFIT test kit containing the materials listed below will be delivered to participating GP practices. 1. qFIT test 2. Patient Information Sheet (explaining the rationale and aims of the pilot) 3. Instructions for the qFIT test 4. Pre-labelled return envelope Training will be offered for participating practices. To get involved Please complete the expression of interest form at the end of this letter by 16 September 2016. For further information about this qFIT pilot study please contact: Helga E Laszlo at [email protected] or on 07598017374 or Claire Levermore at [email protected] or on 07855 169040 Expression of Interest By emailing the completed form to [email protected] by 16th September 2016 you express interest in taking part in the qFIT Pilot. We will get in touch with you about the next steps. Name of GP Practice: Address of GP practice: Main contact person: Telephone: Email: Number of GPs in your practice: Average Suspected Colorectal Cancer 2ww Referral/month in your practice: Do you use an electronic patient record (EPR) system? □ Yes Please specify: □ No Would you like to get more information about this pilot? □ Yes (□ via email / □ via phone / □ meeting in person ) □ No Other comments