An Investigation on Cytosponge and Molecular Biomarkers to Identify Patients With Gastric Intestinal Metaplasia (GIM)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 the utility of the Cytosponge in combination with molecular biomakers to diagnose GIM

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Any participant 18 years and above clinically fit for an endoscopy with GIM of the proximal stomach confirmed on previous biopsies or gastric adenocarcinoma of intestinal type (cases)

• Any participant 18 years and above clinically fit for an endoscopy with upper GI symptoms leading to referral for endoscopy (controls)

• Ability to provide informed consent

Locations
Other Locations
United Kingdom
Cambridge Clinical Research Centre
RECRUITING
Cambridge
Contact Information
Primary
Massimiliano di Pietro, MD
md460@cam.ac.uk
01223763349
Backup
Andreas Hadjinicolaou, MD PhD
ah499@cam.ac.uk
01223763349
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 226
Treatments
Cases
This will include patients with:~* existing diagnosis of proximal GIM undergoing endoscopic surveillance~* a new diagnosis of proximal GIM requiring repeat endoscopy~* a historical diagnosis of GIM retrieved from the pathology records through retrospective analysis and lost in follow up~* gastric adenocarcinoma from upper GI multidisciplinary meeting.
Controls
Controls will be patients with no known premalignant conditions of the upper GI tract and fit to undergo an upper endoscopy. They will be recruited via standard referral routes for upper GI endoscopy due to upper GI symptoms via standard referral routes. Individuals must be able to provide informed consent.
Related Therapeutic Areas
Sponsors
Collaborators: Nottingham University Hospitals NHS Trust, University College London Hospitals
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov