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

NCT02325323 | Unknown

• 1 other identifier: 12-DLE-GASTRIMED
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Cancer

Keywords

stomach cancer; gastric intestinal metaplasia; prospective cohort; low grade dysplasia; high grade dysplasia; prognosis factor; gastric cancer risks

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percentage of development of low grade dysplasia

  3 years

• Percentage of development of gastric cancer or high grade dysplasia

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 years.
• Patient does not oppose to participate to the study.

You may not qualify if:

• Progressive concomitant disease with life expectancy less than 3 years.
• Patient with previous oesophageal cancer.
• Patient with previous gastric surgery.
• Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Société nationale française de gastro-entérologie: collaborator

Study Sites (1)

Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré

Boulogne-Billancourt, Île-de-France Region, 92100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy slides.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Dominique LAMARQUE, MD, PhD

  Hôpital Ambroise Paré, APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique LAMARQUE, MD, PhD

CONTACT

+33 1 49 09 53 25; dominique.lamarque@apr.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 24, 2014

Record last verified: 2014-11

Locations

FR (1)