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Recruiting NCT03250091

Surveillance of Patients With Precancerous Lesions of the Stomach

— Observational Gastric Cancer Gastric Intestinal Metaplasia Gastric Atrophy Gastric Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper endoscopy with biopsies, Plasma/serum sampling, Biopsies for gastric microbiota, Faecal sample acquisition.
Who it may be relevant to
Registry conditions: Gastric Cancer, Gastric Intestinal Metaplasia, Gastric Atrophy, Gastric Dysplasia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Latvia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Procedure 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
  • Procedure Plasma/serum sampling
    Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
  • Procedure Biopsies for gastric microbiota
    During upper endoscopy biopsies for gastric microbiota analysis will be obtained
  • Procedure Faecal sample acquisition
    Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis

Primary outcome measures

  • Risk stratification [Time frame: At baseline]
Secondary outcome measures (2)
  • Scheduled follow-up procedures (gastroscopies) for high risk group patients [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 [Time frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Latvia · 1 center
  • University of Latvia — Riga

Publications

  • 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 PMID 22198778

Identifiers

NCT: NCT03250091 · 2915

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗