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Surveillance of Patients With Precancerous Lesions of the Stomach

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03250091
Enrollment
2000
Registered
2017-08-15
Start date
2017-06-19
Completion date
2027-12-31
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Gastric Intestinal Metaplasia, Gastric Atrophy, Gastric Dysplasia

Keywords

gastric precancerous lesions, gastric cancer, gastric intestinal Metaplasia, gastric atrophy, gastric dysplasia

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.

Interventions

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

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

PROCEDUREBiopsies for gastric microbiota

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

Sponsors

Digestive Diseases Centre GASTRO
CollaboratorOTHER
Riga East Clinical University Hospital
CollaboratorOTHER_GOV
Academic Histology Laboratory (Latvia)
CollaboratorOTHER
University of Latvia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Risk stratificationAt baselineThe 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

MeasureTime frameDescription
Scheduled follow-up procedures (gastroscopies) for high risk group patientsAt baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completionThe 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 lesionsAt baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completionSignificant differences in the composition of gastric, faecal microbiome (phyla, genera) in cancer patients and patients with precancerous lesions

Countries

Latvia

Contacts

Primary ContactIlze Kikuste, PhD
ikikuste@gmail.com28357349

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026