Ignite Creation Date:
2024-05-06 @ 2:45 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02114411
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2014-04-05
Brief Title:
Gastropanel for Gastric Atrophy and Cancer Risk Assessment
Sponsor:
Biohit Healthcare Ltd
Organization:
Biohit Healthcare Ltd
Study Overview
Official Title:
Gastropanel for Early Detection of Gastric Atrophy and Gastric Cancer Risk
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
At present the diagnosis of most gastric and oesophageal diseases requires an endoscopic examination which is an invasive time-consuming and expensive procedure At present there are few non-invasive methods eg tests for Helicobacter pylori available for the diagnosis of the upper gastrointestinal tract diseases Any of these tests do not however give possibilities for a comprehensive diagnosis of the different phenotypes of gastritis ie whether superficial or atrophic and located in the antrum or corpus Importantly these tests do not give any clues about the severity grade of these lesions as defined by the Sydney and OLGA classification
To obviate the excessive use of this invasive and expensive procedure endoscopy there is an urgent need to develop non-invasive diagnostic tools capable of accurately detecting the patients at high risk for GC ie the different phenotypes of gastritis as well as their related H pylori infections After ELISA-testing for P-PG I p-PG II P-G-17 and P-Hp-Ab in a plasma sample an endoscopic examination can be preserved only for those patients whose GastroPanel test results suggest AG whereas an endoscopic examination can be avoided in subjects with negative GastroPanel result or in whom the test biomarkers indicate a non-atrophic gastritis or a healthy stomach 18 Gastroscopy is also recommended if the GastroPanel examination reveals high acid output P-G-17 below 10 pmoll or chronic H pylori infection with symptoms
This clinical trial is conducted as collaboration between Biohit HealthCare Helsinki Finland and Homerton University Hospital London UK hereafter called the Partners The study is performed in Homerton Hospital supervised by a steering committee consisting of members from both research Partners
Enrolment 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 at least 250 subjects both genders to reach a cohort of 100 patents enriched with equal numbers n25 of all conditions see Section 2 above classified as study endpoints
Patient enrolment 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 Because all patients are enrolled among the subjects attending the 11 Endoscopy clinic due to an appointment to gastroscopy their preparation will be compliant with the preparatory steps needed for the GastroPanel examination details below
Eligible patients are all adult females and males with dyspeptic symptoms epigastric pain bloating and epigastric discomfort However the following patients should be considered non-eligible 1 the patients whose treatment requires surgery or immediate follow-up treatment for major symptoms as well as 2 those that refuse to participate
In this study all patients examined with the GastroPanel test will be subjected to gastroscopy providing the histological confirmation to be used as the gold standard in calculating the performance indicators for the test
All patients participating in this study shall undergo a routine gastroscopy examination which will be complemented by biopsy sampling from the antrum and corpus according to the principles of the Sydney and OLGA classification sampling In endoscopy all observed abnormal mucosal lesions are noted and photographed and if necessary eg suspicion of malignancy subjected to additional biopsy
All statistical analyses will be performed using the SPSS 2100 for Windows IBM NY USA and STATASE 130 software STATA Corp Texas USA The descriptive statistics will be done according to routine procedures Performance indicators sensitivity specificity positive predictive value PPV negative predictive value NPV and their 95CI of individual markers and whole GastroPanel test will be calculated separately for each study endpoint using the STATASE software and the diagti algorithm introduced by Seed et al 2001 This algorithm also calculates the area under ROC Receiver Operating Characteristics called AUC for each biomarker at each endpoint Because GastroPanel is a quantitative ELISA test these ROC curves can be used to identify the optimal sensitivityspecificity 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 STATAs roccomb test with 95CI
To obviate the excessive use of this invasive and expensive procedure endoscopy there is an urgent need to develop non-invasive diagnostic tools capable of accurately detecting the patients at high risk for GC ie the different phenotypes of gastritis as well as their related H pylori infections After ELISA-testing for P-PG I p-PG II P-G-17 and P-Hp-Ab in a plasma sample an endoscopic examination can be preserved only for those patients whose GastroPanel test results suggest AG whereas an endoscopic examination can be avoided in subjects with negative GastroPanel result or in whom the test biomarkers indicate a non-atrophic gastritis or a healthy stomach 18 Gastroscopy is also recommended if the GastroPanel examination reveals high acid output P-G-17 below 10 pmoll or chronic H pylori infection with symptoms
This clinical trial is conducted as collaboration between Biohit HealthCare Helsinki Finland and Homerton University Hospital London UK hereafter called the Partners The study is performed in Homerton Hospital supervised by a steering committee consisting of members from both research Partners
Enrolment 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 at least 250 subjects both genders to reach a cohort of 100 patents enriched with equal numbers n25 of all conditions see Section 2 above classified as study endpoints
Patient enrolment 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 Because all patients are enrolled among the subjects attending the 11 Endoscopy clinic due to an appointment to gastroscopy their preparation will be compliant with the preparatory steps needed for the GastroPanel examination details below
Eligible patients are all adult females and males with dyspeptic symptoms epigastric pain bloating and epigastric discomfort However the following patients should be considered non-eligible 1 the patients whose treatment requires surgery or immediate follow-up treatment for major symptoms as well as 2 those that refuse to participate
In this study all patients examined with the GastroPanel test will be subjected to gastroscopy providing the histological confirmation to be used as the gold standard in calculating the performance indicators for the test
All patients participating in this study shall undergo a routine gastroscopy examination which will be complemented by biopsy sampling from the antrum and corpus according to the principles of the Sydney and OLGA classification sampling In endoscopy all observed abnormal mucosal lesions are noted and photographed and if necessary eg suspicion of malignancy subjected to additional biopsy
All statistical analyses will be performed using the SPSS 2100 for Windows IBM NY USA and STATASE 130 software STATA Corp Texas USA The descriptive statistics will be done according to routine procedures Performance indicators sensitivity specificity positive predictive value PPV negative predictive value NPV and their 95CI of individual markers and whole GastroPanel test will be calculated separately for each study endpoint using the STATASE software and the diagti algorithm introduced by Seed et al 2001 This algorithm also calculates the area under ROC Receiver Operating Characteristics called AUC for each biomarker at each endpoint Because GastroPanel is a quantitative ELISA test these ROC curves can be used to identify the optimal sensitivityspecificity 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 STATAs roccomb test with 95CI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None