Gastropanel *for Early Detection of Gastric Atrophy and Gastric Cancer Risk

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).