Clinical trial NCT02325323: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
Official title: Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Cancer
Keywords: stomach cancer
gastric intestinal metaplasia
prospective cohort
low grade dysplasia
high grade dysplasia
prognosis factor
gastric cancer risks
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Société nationale française de gastro-entérologie
First posted: 2014-12-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastric metaplasia consulting a gastroenterologist in any private or public setting in France.

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

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of gastric cancer or high grade dysplasia of the gastric mucosa
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of development of low grade dysplasia
timeFrame: 3 years
measure: Percentage of development of gastric cancer or high grade dysplasia
timeFrame: 3 years
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré
state: Île-de-France
Study officials:
affiliation: Hôpital Ambroise Paré, APHP
name: Dominique LAMARQUE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: