Using Cytosponge to detect gastric intestinal metaplasia
An Investigation on Cytosponge and Molecular Biomarkers to Identify Patients With Gastric Intestinal Metaplasia (GIM)
This study is testing a new non-invasive test called Cytosponge to see if it can effectively detect early signs of stomach changes that could lead to cancer in people who are already being checked for stomach issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT05657080 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the Cytosponge-TFF3, a non-invasive test, in diagnosing gastric intestinal metaplasia (GIM), a precursor to gastric cancer. Participants will include individuals scheduled for surveillance endoscopy due to GIM or gastric cancer, as well as those referred for upper GI symptoms. The study will compare the sensitivity and specificity of the Cytosponge-TFF3 against standard endoscopic procedures. Additionally, it will explore the use of molecular biomarkers to enhance diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above who are clinically fit for endoscopy and have either confirmed GIM or gastric adenocarcinoma, or those referred for endoscopy due to upper GI symptoms.
Not a fit: Patients with advanced tumors in the oro-pharynx, esophagus, or those with certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of gastric cancer, improving patient outcomes.
How similar studies have performed: Previous studies have shown the Cytosponge-TFF3 to be effective in diagnosing Barrett's esophagus, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cambridge
- Cambridge Clinical Research Centre — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Massimiliano di Pietro, MD — University of Cambridge
- Study coordinator: Massimiliano di Pietro, MD
- Email: md460@cam.ac.uk
- Phone: 01223763349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.