Gastrin, Anti-helicobacter Pylori and Pepsinogen Diagnostic Accuracy Study

NCT07060482 | Not Yet Recruiting DMC

• 1 other identifier: 24-248
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is taking place to find out if a simple blood test can diagnose inflammation in the stomach. Prolonged inflammation in the stomach can lead to Ulcers and even Cancer in the long run. Currently, a camera test is needed to identify inflammation in the stomach. The method being tested in this study may be able to do this using just a pinprick of blood. If this test proves to be good at diagnosing inflammation in the stomach with just a pinprick of blood, it may be used in the future to decide who actually needs to have a full camera test done or not. This could really improve the waiting lists for these camera tests in the future. It may also mean that we can identify problems at an earlier stage.

Conditions

Gastric Atrophy

Keywords

gastric atrophy; pepsinogen; gastrin 17; anti-helicobacter pylori antibodies; gastroscopy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Diagnosed with Gastric Atrophy by GastroPanel QuickTest Compared to Histology

  Diagnostic accuracy of the GastroPanel QuickTest (Biohit) for detecting gastric atrophy, assessed by comparing the combined biomarker panel result-including Gastrin-17, Pepsinogen 1, Pepsinogen 2, and anti-Helicobacter pylori IgG antibodies-against the histological diagnosis of gastric atrophy from gastric biopsies. Accuracy metrics will include sensitivity, specificity, positive predictive value, and negative predictive value.

  This diagnostic accuracy assessment will occur simulatneously at the time of the patients gastroscopy with both the blood sample and gastric biopsies being taken at that time.

Study Arms (1)

Patients presenting for routine diagnostic gastroscopy.

Patients presenting for routine diagnostic gastroscopy.

Diagnostic Test: Panel of biomarkers including Gastrin 17, pepsinogen 1 and 2, and anti-helicobacter pylori antibodies.

Interventions

Panel of biomarkers including Gastrin 17, pepsinogen 1 and 2, and anti-helicobacter pylori antibodies. DIAGNOSTIC_TEST

This study will be assessing the diagnostic accuracy of this panel of biomarkers for diagnosing gastric atrophy in the Irish population for the first time. This reflects the assessment of these biomarkers in diagnosing gastric atrophy in a low-risk Western population.

Patients presenting for routine diagnostic gastroscopy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to evaluate our primary objective of determining the diagnostic accuracy of the point of care immunological lateral flow test in diagnosing Gastric atrophy, we will recruit 240 patients who are presenting to the endoscopy day unit for diagnostic gastroscopy in Beaumont Hospital, Dublin.

You may qualify if:

• Patients presenting for a routine diagnostic gastroscopy.

You may not qualify if:

• Patients presenting for a therapeutic procedure such as dilations or stenting.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Eoghan Burke, MD

  Royal college of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eoghan P Burke

CONTACT

(01) 809 3000; burkeeoghan@rcsi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in Oesophagogastric Surgery

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07