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

December 19, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Île-de-France
      • Boulogne Billancourt, Île-de-France, France, 92100
        • Recruiting
        • Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with gastric metaplasia consulting a gastroenterologist in any private or public setting in France.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa
Time Frame: 3 years
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of development of low grade dysplasia
Time Frame: 3 years
Percentage of development of low grade dysplasia in patients initially with intestinal metaplasia without dysplasia.
3 years
Percentage of development of gastric cancer or high grade dysplasia
Time Frame: 3 years
Percentage of development in 3 years of gastric cancer or high grade dysplasia lesion, in patients initially with low grade dysplasia.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Société nationale française de gastro-entérologie

Investigators

  • Principal Investigator: Dominique LAMARQUE, MD, PhD, Hôpital Ambroise Paré, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (ESTIMATE)

December 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-DLE-GASTRIMED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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