Surveillance of Patients With Precancerous Lesions of the Stomach

University of Latvia

Status: Enrolling

Conditions: Gastric Atrophy; Gastric Cancer; Gastric Intestinal Metaplasia; Gastric Dysplasia

Treatments: Procedure: Plasma/serum sampling; Procedure: Upper endoscopy with biopsies; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition

Study type: Observational

Funder types: Other

Identifiers

NCT03250091

2915

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 7 patient groups

Gastric cancer

Description:

Gastric adenocarcinoma and other gastric malignancies

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

Gastric mucosal dysplasia

Description:

Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

High-risk IM gastritis stages

Description:

High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

High-risk atrophic gastritis stages

Description:

High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

Extensive gastric intestinal metaplasia

Description:

Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

Extensive atrophy

Description:

Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

Isolated corpus atrophy

Description:

Isolated moderate-to-severe atrophy or IM in the corpus.

Treatment:

Procedure: Biopsies for gastric microbiota

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling