- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02114411
Gastropanel for Gastric Atrophy and Cancer Risk Assessment
Gastropanel *for Early Detection of Gastric Atrophy and Gastric Cancer Risk
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Hackney
-
London, Hackney, United Kingdom, E9 6SR
- Recruiting
- Homerton University Hospital
-
Contact:
- Cinzia Papadia, MD
- Phone Number: 5197 +44 (0) 0208 510 5555
- Email: cinzia.papadia@nhs.net
-
Principal Investigator:
- Cinzia Papadia, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and Specificity of the GastroPanel test for the detection of AG
Time Frame: Within six weeks from enrolment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cinzia Papadia, MD, Homerton University Hospital
- Study Director: Ray Shidrawi, MD, Homerton University Hospital
- Study Chair: Marco Novelli, MD, University College, London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biohit-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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