Surveillance of Patients With Precancerous Lesions of the Stomach
NCT ID: NCT03250091
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2017-06-19
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Gastric cancer
Gastric adenocarcinoma and other gastric malignancies
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Gastric mucosal dysplasia
Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
High-risk IM gastritis stages
High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
High-risk atrophic gastritis stages
High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Extensive gastric intestinal metaplasia
Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Extensive atrophy
Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Isolated corpus atrophy
Isolated moderate-to-severe atrophy or IM in the corpus.
Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Interventions
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Upper endoscopy with biopsies
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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Digestive Diseases Centre GASTRO
OTHER
Riga East Clinical University Hospital
OTHER_GOV
Academic Histology Laboratory (Latvia)
OTHER
University of Latvia
OTHER
Responsible Party
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Principal Investigators
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Marcis Leja, Prof.,PhD
Role: STUDY_DIRECTOR
Institute of Clinical and Preventive Medicine, University of Latvia
Locations
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University of Latvia
Riga, , Latvia
Countries
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Central Contacts
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Facility Contacts
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References
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Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
Other Identifiers
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2915
Identifier Type: -
Identifier Source: org_study_id
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