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

Stomach Cancer Clinical Trial

— GASTRIMED  

Official title:

Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02325323
• Other study ID #: 12-DLE-GASTRIMED
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2014
• Last updated: December 19, 2014
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dominique LAMARQUE, MD, PhD
• Phone: +33 1 49 09 53 25
• Email: dominique.lamarque[@]apr.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metaplasia
• Stomach Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
France	Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré	Boulogne Billancourt	Île-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Société nationale française de gastro-entérologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of gastric cancer or high grade dysplasia of the gastric mucosa	Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.	3 years	No
Secondary	Percentage of development of low grade dysplasia	Percentage of development of low grade dysplasia in patients initially with intestinal metaplasia without dysplasia.	3 years	No
Secondary	Percentage of development of gastric cancer or high grade dysplasia	Percentage of development in 3 years of gastric cancer or high grade dysplasia lesion, in patients initially with low grade dysplasia.	3 years	No