Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

• Conditions: Stomach Cancer

• Registration Number: NCT02325323
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.

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

This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.

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

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-11
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Last Update Submitted: 2014-12-19
• Study First Posted: 2014-12-24
• Last Update Posted: 2014-12-24
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age > 18 years.
• 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

• Progressive concomitant disease with life expectancy less than 3 years.
• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa	3 years	Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.

Secondary Outcome Measures

Name	Time	Method
Percentage of development of low grade dysplasia	3 years	Percentage of development of low grade dysplasia in patients initially with intestinal metaplasia without dysplasia.
Percentage of development of gastric cancer or high grade dysplasia	3 years	Percentage of development in 3 years of gastric cancer or high grade dysplasia lesion, in patients initially with low grade dysplasia.

Trial Locations

Locations (1)

Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré; 🇫🇷 Boulogne Billancourt, Île-de-France, France