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Clinical Trials/NCT03250091
NCT03250091
Recruiting
Not Applicable

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

University of Latvia1 site in 1 country2,000 target enrollmentJune 19, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
University of Latvia
Enrollment
2000
Locations
1
Primary Endpoint
Risk stratification
Status
Recruiting
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 19, 2017
End Date
December 2027
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Risk stratification

Time Frame: At baseline

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

Secondary Outcomes

  • Scheduled follow-up procedures (gastroscopies) for high risk group patients(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(At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion)

Study Sites (1)

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