Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Syndrome

Stomach Neoplasms

Atrophy

Gastritis, Atrophic

Gastritis

Gastrointestinal Diseases

Stomach Diseases

Gastroenteritis

Chronic Graft Versus Host Disease

Stomach Cancer

Healthy Volunteers with Balanced Constitution(n=10).

Healthy Volunteers with Qi Deficiency Constitution(n=10).

Healthy Volunteers with Damp-heat Constitution(n=10).

Superficial Gastritis with Spleen-qi Deficiency Syndrome(n=10).

Superficial Gastritis with Damp-heat Syndrome(n=10).

Atrophic Gastritis with Spleen-qi Deficiency Syndrome(n=10).

Atrophic Gastritis with Damp-heat Syndrome(n=10).

Gastric Cancer with Spleen-qi Deficiency Syndrome(n=10).

Gastric Cancer with Damp-heat Syndrome(n=10).

Xiaopu Sang

Leiming You

Anlong Xu

Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.

System Biology of Spleen Deficiency Syndrome

System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"

Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.

Pathological diagnosis standard of chronic gastritis according to Chinese Society of Gastroenterology.Pathological diagnosis standard of gastric cancer according to Ministry of Health P.R.China

Beijing University of Chinese Medicine

President

Pathological Conditions, Anatomical

Gastrointestinal Neoplasms

Digestive System Neoplasms

All Drugs and Chemicals

Antibodies

Immunoglobulins

Gastrins

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).

GastroPanel test

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.

Gastroscopy

Cinzia Papadia, MD

Ray Shidrawi, MD

Marco Novelli, MD

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.

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.

Gastropanel for Gastric Atrophy and Cancer Risk Assessment

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

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.

Biohit Healthcare Ltd

Infections

Communicable Diseases

Helicobacter Infections

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Gastrointestinal Agents

Rabeprazole

Pantoprazole

Lansoprazole

Dexlansoprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

Participants who are diagnosed with Helicobacter Pylori infection through ESD(endoscopic submucosal dissection) will be treated with PPI (proton pump inhibitor).

1. Pre ESD (endoscopic submucosal dissection)

   * Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
   * Use of PPI for 2 months
2. Post ESD 1 (After 2 months)

   * Assess the distribution of helicobacter pylori after using PPI.
   * Stop of PPI
3. Post ESD 2 (After 4 months)

   * Assess the distribution of helicobacter pylori after stop of PPI.

PPI (proton pump inhibitor)

Ji Yong Ahn, Professor

The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.

Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
System Biology of Spleen Deficiency Syndrome	NCT02915393	Gastritis, Atro... Gastric Cancer		18 Years - 65 Years	Beijing University of Chinese Medicine
Gastropanel for Gastric Atrophy and Cancer Risk Assessment	NCT02114411	Gastritis, Atro... Stomach Neoplas...	GastroPanel tes... Gastroscopy	45 Years -	Biohit Healthcare Ltd
Helicobacter Pylori and Proton Pump Inhibitor	NCT02449941	Helicobacter In...	PPI (proton pum...	19 Years - 65 Years	Asan Medical Center

Spots Global Cancer Trial Database for gastritis, atrophic