RecruitingNCT05657080

Cytosponge for Gastric Intestinal Metaplasia

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


Sponsor

University of Cambridge

Enrollment

226 participants

Start Date

Oct 16, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a swallowable sponge capsule called the Cytosponge (swallowed, then pulled back up by a string) can detect pre-cancerous changes in the stomach lining (gastric intestinal metaplasia) as effectively as a traditional endoscopy. **You may be eligible if...** - You are 18 or older and medically fit for an endoscopy - You have been previously diagnosed with gastric intestinal metaplasia (a pre-cancerous change in the stomach lining) — if joining as a "case" participant - You have upper digestive symptoms and are referred for endoscopy — if joining as a "control" participant **You may NOT be eligible if...** - You have been diagnosed with a tumor of the throat, esophagus, or stomach (T2 or higher) - You have Barrett's esophagus, esophageal varices, strictures, or need esophageal dilation - You take blood thinners that cannot be safely stopped before the procedure - You have trouble swallowing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECytosponge-TFF3

Cytosponge is a less invasive procedure than endoscopy and consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Five minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter can be retrieved by pulling on the string. Upon retrieval the Cytosponge scrapes against the surface of the top of the stomach and oesophagus and collect epithelial cells. The Cytosponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests. Trefoil Factor 3 (TFF3) is a protein that is expressed in intestinal type epithelia of the gastrointestinal tract. TFF3 is the best biomarker, which can be coupled to the Cytosponge to diagnose intestinal metaplasia.


Locations(1)

Cambridge Clinical Research Centre

Cambridge, United Kingdom

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NCT05657080


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