CyGIM_v1

• Research type

  Research Study

• Full title

  An investigation on Cytosponge and molecular biomarkers to identify patients with gastric intestinal metaplasia (GIM)

• IRAS ID

  307845

• Contact name

  Massimiliano di Pietro

• Contact email

  md460@cam.ac.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

• Clinicaltrials.gov Identifier

  NCT05657080

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Gastric cancer has a very poor prognosis. The disease is often diagnosed at a late stage, when curative treatment options are limited or ineffective. There is a condition that predisposes to gastric cancer, known in medical terms as Gastric intestinal metaplasia (GIM). This pre-cancerous condition can be diagnosed with an endoscopic camera test, but it often very subtle and can be missed at routine endoscopy. There is evidence that about 7% of gastric cancers are missed at previous endoscopy.
  The Cytosponge-trefoil factor 3 (TFF-3) is a pill on a string combined to a molecular biomarker which could help early diagnosis of gastric cancer and GIM. Cytosponge-TFF3 has been showed in previous research to be useful to diagnose Barrett's oesophagus, a condition of the food pipe similar to GIM. The aim of this study is to investigate if the Cytosponge-TFF3 can detect GIM in patients already known with this condition and differentiate them from control individuals without the condition. Furthermore, we will also investigate if any other biomarkers on blood, tissue samples and gastric juice that could be beneficial in detecting this condition with better accuracy. We will ask patients referred for an endoscopy to swallow the Cytosponge prior to their procedure. The goal is to develop a non-invasive test which can be used to screen patients at risk for GIM to allow early detection and treatment of pre-cancerous gastric lesions and ultimately reduce the number of patients dying of gastric cancer

• REC name

  West of Scotland REC 3

• REC reference

  23/WS/0028

• Date of REC Opinion

  13 Apr 2023

• REC opinion

  Further Information Favourable Opinion