An observational study in Gastric Cancer, Gastric Intestinal Metaplasia and Gastric Atrophy, sponsored by University of Latvia. Recruiting at 1 site in Latvia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by University of Latvia · Observational
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.
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.
The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progression to gastric cancer (Group 2-7).
The appropriate follow-up intervals will be scheduled according MAPS guidelines and follow-up procedures (upper endoscopies) will be performed for each research group (Group 2-7).
Patients undergoing upper endoscopy Motivation to participate in the study Signed consent
Exclusion Criteria:
Known gastric cancer Unwillingness or inability to co-operate
Gastric adenocarcinoma and other gastric malignancies
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
Isolated moderate-to-severe atrophy or IM in the corpus.
Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Biopsies for gastric microbiota · Procedure: Faecal sample acquisition
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
Also known as: gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
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
Time frame: At baseline
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.
Time frame: 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
Time frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Plan to share: No
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University of Latvia