Surveillance of Patients With Precancerous Lesions of the Stomach

August 20, 2018 updated by: University of Latvia

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

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progression to gastric cancer (Group 2-7).

The appropriate follow-up intervals will be scheduled according MAPS guidelines and follow-up procedures (upper endoscopies) will be performed for each research group (Group 2-7).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric cancer
Gastric adenocarcinoma and other gastric malignancies
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Gastric mucosal dysplasia
Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
High-risk IM gastritis stages
High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
High-risk atrophic gastritis stages
High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Extensive gastric intestinal metaplasia
Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Extensive atrophy
Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Isolated corpus atrophy
Isolated moderate-to-severe atrophy or IM in the corpus.
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
Other Names:
  • gastroscopy, upper endoscopy
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
Significant differences in the composition of gastric, faecal microbiome (phyla, genera) 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Marcis Leja, Prof.,PhD, Institute of Clinical and Preventive Medicine, University of Latvia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2017

Primary Completion (Anticipated)

May 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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