- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03250091
Surveillance of Patients With Precancerous Lesions of the Stomach
Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ilze Kikuste, PhD
- Phone Number: +371 28357349
- Email: ikikuste@gmail.com
Study Locations
-
-
-
Riga, Latvia, LV 1586
- Recruiting
- University of Latvia
-
Contact:
- Ilze Kikuste, PhD
- Phone Number: +317 28357349
- Email: ikikuste@gmail.com
-
Contact:
- Marcis Leja, Prof., PhD
- Email: marcis.leja@lu.lv
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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:
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:
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:
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:
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:
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:
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:
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
Sponsor
Collaborators
Investigators
- Study Director: Marcis Leja, Prof.,PhD, Institute of Clinical and Preventive Medicine, University of Latvia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2915
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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