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Gastropanel *for Early Detection of Gastric Atrophy and Gastric Cancer Risk
Sponsor study identifier
observational
250
1 country
1
Study Start
January 31, 2017
Actual (reported)Primary Completion
October 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: Atrophic gastritis (AG) is the single most important precursor condition for gastric cancer (GC) known so far. H. pylori infection is the most important causative agent of gastritis, and subsequent AG. The GastroPanel test (Biohit HealthCare, Helsinki, Finland), a blood test evaluating the four biomarkers specific for the gastric mucosa pepsinogen I (P-PGI), pepsinogen II (P-PGII), gastrin-17 (P-G-17) and H. pylori antibody (P-HpAb), is the first non-invasive diagnostic tool providing possibilities for detecting the patients at risk for GC and peptic ulcer as well as malabsorption of vitamin B12, iron, magnesium, calcium and some drugs. A well designed clinical study is warranted to fully assess the performance of GastroPanel examination in detecting the gastric lesions which can lead to GC. The investigators aim to perform a clinical study in an adult population in United Kingdom in order to determine the diagnostic accuracy of the GastroPanel test in evaluating AG and other specific gastric conditions associated with an increased risk for GC. Methods: Two hundred and fifty patients (45 years and older, both genders) will be enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United Kingdom). During the same visit, all patients are subjected to gastroscopy examination, with directed biopsies from the antrum and corpus, following the protocol of the operative link on gastritis assessment (OLGA) classification for chronic gastritis and Sydney Classification. Biopsies are examined at the Pathology laboratory of Homerton University Hospital and interpreted using the OLGA staging system as well as the Sydney system for classification of gastritis. Specific aims: The principal goal of this clinical trial is to establish the performance of the GastroPanel examination in detecting AG and other specific gastric conditions associated with an increased risk for GC. In particular, the investigators will evaluate AG in the antrum, AG in the corpus, AG in both antrum and corpus (=atrophic pangastritis), biopsy-confirmed dysplasia (intestinal metaplasia) of the gastric mucosa. For all these conditions, the investigators will calculate the diagnostic accuracy of the GastroPanel test.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2014
Actual (reported)April 15, 2014
Actual (reported)January 31, 2017
Actual (reported)October 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sensitivity and Specificity of the GastroPanel test for the detection of AG
Performance indicators (sensitivity, specificity, positive predictive value, PPV, negative predictive value, NPV and their 95%CI) of individual markers and whole GastroPanel test will be calculated separately for each study endpoint, using the STATA/SE software . The area under ROC (Receiver Operating Characteristics) called AUC, will be identified for each biomarker at each endpoint. Because GastroPanel is a quantitative ELISA test, these ROC curves can be used to identify the optimal sensitivity/specificity balance that gives each biomarker an optimal threshold for detection of each study endpoint. Significance of the difference between AUC values can be estimated using STATA's roccomb test with 95%CI.
Within six weeks from enrolment
Patients (45 years and older, both genders) with dyspepsia referred for the GastroPanel test and gastroscopy with multiple bisopies at Homerton University Hospital (London, United Kingdom).
Dyspeptic patients will be referred for the GastroPanel test, containing four biomarkers specific for the gastric mucosa: 1) Pepsinogen I (P-PGI), 2) Pepsinogen II (P-PGII), 3) Gastrin-17 (P-G-17) and 4) H. pylori antibody (P-HpAb).
Dyspeptic patients will undergo gastroscopy examination, with targeted biopsies from the antrum and corpus, following the protocol of the OLGA classification for chronic gastritis and Sydney Classification.
Enrollment of the patients in the study will take place at Homerton Hospital including consecutive patients over 45 years of age, referred for gastroscopy at the Outpatient Department of Endoscopy. The estimated cohort to be screened is 250 subjects (both genders), to reach a cohort of 100 patents enriched with equal numbers (n=25) of all conditions classified as study endpoints. Patient enrollment is taking place in a single step. In brief, the potentially eligible patients are identified among the gastroscopy-referral outpatients by the members of the research team. At this stage, every patient will be asked to consent the study and sign a written consent to participate.
Homerton University Hospital
London, Hackney, E9 6SR, United Kingdom
Cinzia Papadia, MD
Homerton University Hospital
Ray Shidrawi, MD
Homerton University Hospital
Marco Novelli, MD
University College, London
First Submitted
April 5, 2014
First Posted
April 15, 2014
Study Start
January 31, 2017
Actual (reported)Primary Completion
October 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
January 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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