Surveillance of Patients With Precancerous Lesions of the Stomach

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Risk stratification [Срок оценки: At baseline]

Вторичные конечные точки (2)

• Scheduled follow-up procedures (gastroscopies) for high risk group patients [Срок оценки: 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 [Срок оценки: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion]

Критерии участия

Критерии включения

Patients undergoing upper endoscopy Motivation to participate in the study Signed consent

Критерии исключения

Known gastric cancer Unwillingness or inability to co-operate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Латвия · 1 центр

• University of Latvia — Riga

Публикации

• 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 PMID 22198778

Идентификаторы

NCT: NCT03250091 · 2915

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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