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NCT Number: NCT03250091

Surveillance of Patients With Precancerous Lesions of 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.

Recruiting

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric Atrophy Gastric Dysplasia Gastric Intestinal Metaplasia Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper endoscopy with biopsies

Procedure

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

Procedure

Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers

Biopsies for gastric microbiota

Procedure

During upper endoscopy biopsies for gastric microbiota analysis will be obtained

Faecal sample acquisition

Procedure

Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis

Primary outcomes

  1. 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

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ilze Kikuste, PhD

CONTACT

[email protected]

28357349 ext. +371

Sponsors and collaborators

Lead sponsor

University of Latvia

Other

Collaborators

  • Academic Histology Laboratory (Latvia)
  • Digestive Diseases Centre GASTRO
  • Riga East Clinical University Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2017
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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