Surveillance of Patients With Precancerous Lesions of the Stomach

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250091
• Other study ID #: 2915
• Status: Recruiting
• Start date: June 19, 2017
• Est. completion date: December 2027

Study information

• Verified date: August 2018
• Source: University of Latvia
• Contact: Ilze Kikuste, PhD
• Phone: 28357349
• Email: ikikuste[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Gastric Atrophy
• Gastric Cancer
• Gastric Dysplasia
• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia
• Stomach Neoplasms

Intervention

Procedure:
• Upper endoscopy with biopsies
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
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
• Biopsies for gastric microbiota
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
• Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis

Locations

Country	Name	City	State
Latvia	University of Latvia	Riga

Sponsors (4)

Lead Sponsor	Collaborator
University of Latvia	Academic Histology Laboratory (Latvia), Digestive Diseases Centre Gastro (Latvia), Riga East University Hospital (Latvia)

Country where clinical trial is conducted

Latvia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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