Surveillance of Patients With Precancerous Lesions of the Stomach
Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2017
CompletedFirst Submitted
Initial submission to the registry
July 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 21, 2018
August 1, 2018
9.9 years
July 21, 2017
August 20, 2018
Conditions
Keywords
Outcome Measures
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
At baseline
Secondary Outcomes (2)
Scheduled follow-up procedures (gastroscopies) for high risk group patients
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
At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Study Arms (7)
Gastric cancer
Gastric adenocarcinoma and other gastric malignancies
Gastric mucosal dysplasia
Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
High-risk IM gastritis stages
High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
High-risk atrophic gastritis stages
High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
Extensive gastric intestinal metaplasia
Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
Extensive atrophy
Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
Isolated corpus atrophy
Isolated moderate-to-severe atrophy or IM in the corpus.
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
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
Eligibility Criteria
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).
You may qualify if:
- Patients undergoing upper endoscopy Motivation to participate in the study Signed consent
You may not qualify if:
- Known gastric cancer Unwillingness or inability to co-operate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Latvialead
- Digestive Diseases Centre GASTROcollaborator
- Riga East Clinical University Hospitalcollaborator
- Academic Histology Laboratory (Latvia)collaborator
Study Sites (1)
University of Latvia
Riga, LV 1586, Latvia
Related Publications (1)
Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
PMID: 22198778BACKGROUND
Biospecimen
Human biopsy samples that are used for histopathology analysis are containing human DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marcis Leja, Prof.,PhD
Institute of Clinical and Preventive Medicine, University of Latvia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2017
First Posted
August 15, 2017
Study Start
June 19, 2017
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 21, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share