Gastrin, Anti-helicobacter Pylori and Pepsinogen Diagnostic Accuracy Study
ConditionGastric Atrophy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting for a routine diagnostic gastroscopy.
Disqualifiers
Patients presenting for a therapeutic procedure such as dilations or stenting.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Panel of biomarkers including Gastrin 17, pepsinogen 1 and 2, and anti-helicobacter pylori antibodies.
Diagnostic testThis 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.
Treatment groups
240 Participants
are divided into 1 treatment groupGroup A: Patients presenting for routine diagnostic gastroscopy.1 intervention
Trial outcomes
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.
Time frame
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: