Surveillance of Patients With Precancerous Lesions of the Stomach
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Latvia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Upper endoscopy with biopsies
Procedure/SurgeryUpper 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
Procedure/SurgeryPlasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiota
Procedure/SurgeryDuring upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisition
Procedure/SurgeryFaecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Treatment groups
2,000 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Gastric cancer4 interventions
Group B: Gastric mucosal dysplasia4 interventions
Group C: High-risk IM gastritis stages4 interventions
Group D: High-risk atrophic gastritis stages4 interventions
Group E: Extensive gastric intestinal metaplasia4 interventions
Group F: Extensive atrophy4 interventions
Group G: Isolated corpus atrophy4 interventions
Trial outcomes
Primary outcomes
1
Risk stratification
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
Time frame
At baselineSecondary outcomes
1
Scheduled follow-up procedures (gastroscopies) for high risk group patients
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.
Time frame
At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion2
Gastric, faecal microbiome in cancer patients and patients with precancerous lesions
Significant differences in the composition of gastric, faecal microbiome (phyla, genera) 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 completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Latvia
Lead sponsor
Digestive Diseases Centre GASTRO
Collaborator
Riga East Clinical University Hospital
Collaborator
Academic Histology Laboratory (Latvia)
Collaborator
Source ClinicalTrials.gov