Gastropanel for Gastric Atrophy and Cancer Risk Assessment

NCT02114411 | Unknown DMC

• 1 other identifier: Biohit-001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dyspeptic patients

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).

Procedure: GastroPanel test; Procedure: Gastroscopy

Interventions

GastroPanel test PROCEDURE

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

Gastroscopy PROCEDURE

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.

Dyspeptic patients

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult females and males over 45 years of age with dyspeptic symptoms (epigastric pain, bloating and epigastric discomfort)

You may not qualify if:

• Patients who require surgery or immediate follow-up treatment for major symptoms, including hematemesis, melena, acute epigastric pain
• Patients who previously underwent upper gastrointestinal surgery
• Patients with diabetes
• Pregnant women
• Subjects who refuse to participate or are unable to give consent

Sponsors & Collaborators

• Biohit Healthcare Ltd: lead

Study Sites (1)

Homerton University Hospital

London, Hackney, E9 6SR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Cinzia Papadia, MD

  Homerton University Hospital

  PRINCIPAL INVESTIGATOR

• Ray Shidrawi, MD

  Homerton University Hospital

  STUDY DIRECTOR

• Marco Novelli, MD

  University College, London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 15, 2014
• Study Start: January 31, 2017
• Primary Completion: October 1, 2018
• Study Completion: January 31, 2019
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

GB (1)