Actively Recruiting
Cytosponge for Gastric Intestinal Metaplasia
Led by University of Cambridge · Updated on 2024-05-08
226
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
U
University College London Hospitals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Cytosponge for Gastric Intestinal Metaplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years and older who are clinically fit for endoscopy with GIM of the proximal stomach confirmed by previous biopsies or gastric adenocarcinoma of intestinal type (cases)
- Participants 18 years and older who are clinically fit for endoscopy with upper gastrointestinal symptoms leading to referral for endoscopy (controls)
- Ability to provide informed consent
You will not qualify if you...
- Diagnosis of oro-pharynx, oesophageal, or gastro-oesophageal tumor (T2 stage or higher) or symptoms of difficulty swallowing
- Previous diagnosis of Barrett's oesophagus, oesophageal varices, stricture, or need for oesophageal dilation
- Unable to stop anticoagulation therapy (heparin or tinzaparin, apixaban, rivaroxaban, dabigatran, edoxaban within 48 hours; warfarin within 5 days; clopidogrel within 7 days) before the procedure
- Myocardial infarction or cardiac event within the last 6 months
- Cerebrovascular event less than 6 months ago affecting swallowing
- Previous treatments like Photodynamic therapy, Radiofrequency ablation, or Argon Plasma Coagulation for dysplastic Barrett's oesophagus
- Unable to provide informed consent
- Under 18 years of age
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cambridge Clinical Research Centre
Cambridge, United Kingdom, CB20QQ
Actively Recruiting
Research Team
M
Massimiliano di Pietro, MD
CONTACT
A
Andreas Hadjinicolaou, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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