Clinical trial NCT03250091: Surveillance of Patients With Precancerous Lesions of the Stomach
Official title: Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Gastric Intestinal Metaplasia
Gastric Atrophy
Gastric Dysplasia
Keywords: gastric precancerous lesions
gastric cancer
gastric intestinal Metaplasia
gastric atrophy
gastric dysplasia
Lead sponsor: University of Latvia
Sponsor class: OTHER
Collaborators: name: Digestive Diseases Centre GASTRO
name: Riga East Clinical University Hospital
name: Academic Histology Laboratory (Latvia)
First posted: 2017-08-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk stratification
timeFrame: At baseline
Secondary outcomes:
measure: Scheduled follow-up procedures (gastroscopies) for high risk group patients
timeFrame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
measure: Gastric, faecal microbiome in cancer patients and patients with precancerous lesions
timeFrame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: University of Latvia
Study officials:
affiliation: Institute of Clinical and Preventive Medicine, University of Latvia
name: Marcis Leja, Prof.,PhD
role: STUDY_DIRECTOR
References:
citation: 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.