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| Name | Class |
|---|---|
| Digestive Diseases Centre GASTRO | OTHER |
| Riga East Clinical University Hospital | OTHER_GOV |
| Academic Histology Laboratory (Latvia) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion |
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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
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilze Kikuste, PhD | Contact | 28357349 | +371 | ikikuste@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcis Leja, Prof.,PhD | Institute of Clinical and Preventive Medicine, University of Latvia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Latvia | Recruiting | Riga | LV 1586 | Latvia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22198778 | Background | 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005757 | Gastritis, Atrophic |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Human biopsy samples that are used for histopathology analysis are containing human DNA
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. |
|
|
| 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 |
|
| 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 | At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |