Surveillance of Patients With Precancerous Lesions of the Stomach

Recruiting

• Conditions: Gastric Cancer; Gastric Intestinal Metaplasia; Gastric Dysplasia; Gastric Atrophy
• Interventions: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition

• Registration Number: NCT03250091
• Lead Sponsor: University of Latvia

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.

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2027-05
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric cancer	Plasma/serum sampling	Gastric adenocarcinoma and other gastric malignancies
Extensive atrophy	Plasma/serum sampling	Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
Gastric cancer	Biopsies for gastric microbiota	Gastric adenocarcinoma and other gastric malignancies
Gastric mucosal dysplasia	Upper endoscopy with biopsies	Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
Gastric mucosal dysplasia	Biopsies for gastric microbiota	Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
High-risk IM gastritis stages	Faecal sample acquisition	High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
High-risk atrophic gastritis stages	Plasma/serum sampling	High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
Isolated corpus atrophy	Faecal sample acquisition	Isolated moderate-to-severe atrophy or IM in the corpus.
Gastric mucosal dysplasia	Plasma/serum sampling	Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
Gastric mucosal dysplasia	Faecal sample acquisition	Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
High-risk atrophic gastritis stages	Biopsies for gastric microbiota	High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
High-risk atrophic gastritis stages	Faecal sample acquisition	High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
Extensive gastric intestinal metaplasia	Plasma/serum sampling	Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Extensive atrophy	Biopsies for gastric microbiota	Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
High-risk IM gastritis stages	Upper endoscopy with biopsies	High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
High-risk IM gastritis stages	Biopsies for gastric microbiota	High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
Extensive gastric intestinal metaplasia	Upper endoscopy with biopsies	Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Extensive gastric intestinal metaplasia	Biopsies for gastric microbiota	Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Extensive gastric intestinal metaplasia	Faecal sample acquisition	Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Extensive atrophy	Upper endoscopy with biopsies	Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
Isolated corpus atrophy	Plasma/serum sampling	Isolated moderate-to-severe atrophy or IM in the corpus.
Gastric cancer	Upper endoscopy with biopsies	Gastric adenocarcinoma and other gastric malignancies
Gastric cancer	Faecal sample acquisition	Gastric adenocarcinoma and other gastric malignancies
Extensive atrophy	Faecal sample acquisition	Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
High-risk IM gastritis stages	Plasma/serum sampling	High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
High-risk atrophic gastritis stages	Upper endoscopy with biopsies	High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
Isolated corpus atrophy	Upper endoscopy with biopsies	Isolated moderate-to-severe atrophy or IM in the corpus.
Isolated corpus atrophy	Biopsies for gastric microbiota	Isolated moderate-to-severe atrophy or IM in the corpus.

Primary Outcome Measures

Name	Time	Method
Risk stratification	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 Outcome Measures

Name	Time	Method
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	The subgroup of patients at different risk of progression to gastric cancer will be selected and appropriate follow-up intervals will be scheduled and performed. Significant risk stage changes before and after the follow-up upper endoscopy in different research groups.
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	Significant differences in the composition of gastric, faecal microbiome (phyla, genera) in cancer patients and patients with precancerous lesions

Trial Locations

Locations (1)

University of Latvia; 🇱🇻 Riga, Latvia