Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
NCT ID: NCT02325323
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2014-05-31
2015-06-30
Brief Summary
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As secondary objectives, among the patients included in the cohort, the study will:
* assess the incidence of low grade dysplasia,
* assess the incidence of high grade dysplasia in patients with low grade dysplasia,
* identify risk factors of progression to dysplasia and gastric cancer.
Detailed Description
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All patients will undergo an endoscopy with gastric sampling in order to biopsy:
* 1 sample each in anterior and posterior surfaces of antrum
* 1 sample in lesser curvature
* 1 sample each in anterior and posterior surfaces of body of stomach
Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.
During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:
* patients with intestinal metaplasia: gastroscopy at 36 months.
* patients with dysplasia: an annual gastroscopy will be performed.
In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:
* 4 circumferential samplings of antrum
* 1 sampling of curvature
* 4 circumferential samplings of body of stomach
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Gastroscopic examination with biopsy in the 6 months preceding inclusion, with intestinal metaplasia in body of stomach or angular incisure.
* Patient does not oppose to participate to the study.
Exclusion Criteria
* Gastric cancer at the time of inclusion.
* Patient with previous oesophageal cancer.
* Patient with previous gastric surgery.
* Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).
18 Years
ALL
No
Sponsors
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Société nationale française de gastro-entérologie
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Dominique LAMARQUE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Ambroise Paré, APHP
Locations
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Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Île-de-France Region, France
Countries
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Central Contacts
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Other Identifiers
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12-DLE-GASTRIMED
Identifier Type: -
Identifier Source: org_study_id