Cytosponge for Gastric Intestinal Metaplasia

Launched by UNIVERSITY OF CAMBRIDGE · Dec 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method called Cytosponge-trefoil factor 3 (TFF-3) to help diagnose a pre-cancerous condition known as gastric intestinal metaplasia (GIM), which can lead to gastric cancer. Many people with GIM may not be diagnosed early enough because it can be missed during routine endoscopy, a procedure where a small camera is used to look inside the stomach. By using the Cytosponge, which is a pill on a string that collects cells from the stomach, researchers hope to improve the early detection of GIM and potentially prevent gastric cancer from developing.

To participate in this trial, individuals must be at least 18 years old, be healthy enough for an endoscopy, and have either a confirmed diagnosis of GIM or upper gastrointestinal symptoms that require an endoscopy. Participants will be asked to swallow the Cytosponge, which is a simple and non-invasive process. It’s important to know that certain health conditions or recent medical events may exclude someone from participating, such as recent heart attacks or specific types of cancers. Overall, this trial aims to enhance the way we detect gastric conditions early, ultimately improving outcomes for patients at risk of gastric cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia.
• • Patients with previous diagnosis of Barrett's oesophagus oesophageal varices, stricture or requiring dilatation of the oesophagus.
• • Patients unable to stop anticoagulation therapy/medication timely before the procedure (heparin or tinzaparin, apixaban, rivaroxaban, dabigatran, edoxaban; 48 hours, warfarin; 5 days, clopidogrel; 7 days)
• • Individuals who have had a myocardial infarction or any cardiac event less than six months ago.
• • Individuals who have had a cerebrovascular event \< 6 months ago where their swallowing has been affected
• • Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation or Argon Plasma Coagulation for dysplastic Barrett's oesophagus
• • Participants who are unable to provide informed consent.
• • Participants under age 18.
• • NB - Endoscopy is generally avoided in pregnant women and therefore it is unlikely that any pregnant women will be included although pregnancy would not be an absolute contraindication. Pregnancy/ pregnancy test will not be recorded as part of the trial.