Trial Title:
Gastropanel for Gastric Atrophy and Cancer Risk Assessment
NCT ID:
NCT02114411
Condition:
Gastritis, Atrophic
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Gastritis
Gastritis, Atrophic
Atrophy
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
GastroPanel test
Description:
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).
Arm group label:
Dyspeptic patients
Intervention type:
Procedure
Intervention name:
Gastroscopy
Description:
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.
Arm group label:
Dyspeptic patients
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 (e.g. 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, i.e., 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, i.e. 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
1,0 pmol/l) 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 (n=25) 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 (e.g. suspicion of
malignancy) subjected to additional biopsy.
All statistical analyses will be performed using the SPSS 21.0.0 for Windows (IBM, NY,
USA) and STATA/SE 13.0 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
95%CI) of individual markers and whole GastroPanel test will be calculated separately for
each study endpoint, using the STATA/SE 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
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Adult females and males over 45 years of age with dyspeptic symptoms (epigastric
pain, bloating and epigastric discomfort)
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Homerton University Hospital
Address:
City:
London
Zip:
E9 6SR
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Cinzia Papadia, MD
Phone:
+44 (0) 0208 510 5555
Phone ext:
5197
Email:
cinzia.papadia@nhs.net
Investigator:
Last name:
Cinzia Papadia, MD
Email:
Principal Investigator
Start date:
January 31, 2017
Completion date:
January 31, 2019
Lead sponsor:
Agency:
Biohit Healthcare Ltd
Agency class:
Industry
Source:
Biohit Healthcare Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02114411
