NCT03250091

Surveillance of Patients With Precancerous Lesions of the Stomach

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Latvia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Gastric Cancer
• Gastric Intestinal Metaplasia
• Gastric Atrophy
• Gastric Dysplasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-19
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2017-08-15
• Last updated: 2018-08-21

Locations

1 site across 1 country: Latvia