Surveillance of Patients With Precancerous Lesions of the Stomach

Study Overview
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Brief Summary
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The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered and performed endoscopic surveillance.

Detailed Description
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Gastric cancer is still an important healthcare problem with significant mortality rates. Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less effective. Ideally, gastric cancer could be prevented by detecting gastric precancerous conditions/lesions and identifying those individuals at high-risk of progressing to cancer to the follow-up. Population based endoscopic screening for gastric cancer is not recommended for the early detection of gastric cancer generally deemed not to be cost-effective. However, in the absence of screening, patients present with advanced disease, and prognosis is poor. Targeted endoscopic surveillance strategies for gastric cancer should be introduced following the principles of the recent European guidelines: Management of precancerous conditions and lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012). The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered endoscopic surveillance.

Official Title
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Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach

Conditions
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Gastric Cancer, Gastric Intestinal Metaplasia, Gastric Atrophy, Gastric Dysplasia

Intervention / Treatment
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* Procedure: Upper endoscopy with biopsies
* Procedure: Plasma/serum sampling
* Procedure: Biopsies for gastric microbiota
* Procedure: Faecal sample acquisition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing upper endoscopy Motivation to participate in the study Signed consent Exclusion Criteria: Known gastric cancer Unwillingness or inability to co-operate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric cancer<br>Gastric adenocarcinoma and other gastric malignancies | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|
| Gastric mucosal dysplasia<br>Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|
| High-risk IM gastritis stages<br>High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III. | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|
| High-risk atrophic gastritis stages<br>High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III. | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|
| Extensive gastric intestinal metaplasia<br>Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV). | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|
| Extensive atrophy<br>Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV. | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|
| Isolated corpus atrophy<br>Isolated moderate-to-severe atrophy or IM in the corpus. | Procedure: Upper endoscopy with biopsies<br>* Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection<br>* Other names: gastroscopy, upper endoscopy;Procedure: Plasma/serum sampling<br>* Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers<br>Procedure: Biopsies for gastric microbiota<br>* During upper endoscopy biopsies for gastric microbiota analysis will be obtained<br>Procedure: Faecal sample acquisition<br>* Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk stratification | The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progressing to gastric cancer. The measurements for the risk stratification will be used following the updated Sydney grading and classification system e.g. degree and extent of atrophy, intestinal metaplasia and dysplasia in the stomach mucosa | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scheduled follow-up procedures (gastroscopies) for high risk group patients | The subgroup of patients at different risk of progression to gastric cancer will be selected and appropriate follow-up intervals will be scheduled and performed. Significant risk stage changes before and after the follow-up upper endoscopy in different research groups. | At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion | 
| Gastric, faecal microbiome in cancer patients and patients with precancerous lesions | Significant differences in the composition of gastric, faecal microbiome (phyla, genera) in cancer patients and patients with precancerous lesions | At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric precancerous lesions, gastric cancer, gastric intestinal Metaplasia, gastric atrophy, gastric dysplasia