Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk

NCT ID: NCT02624271

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-04

Study Completion Date

2019-05-09

Brief Summary

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Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis.

Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.

Detailed Description

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Conditions

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Gastric Cancer Gastric Precancerous Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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GastroPanel

GastroPanel test on blood samples

Group Type EXPERIMENTAL

blood samples analysis

Intervention Type OTHER

Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.

Interventions

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blood samples analysis

Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care
* Patients with increased risk of gastric cancer (at least one of the following criteria):

* age \> 50 years,
* family cases of gastric cancer,
* known precancerous lesions,
* Biermer disease,
* H. Pylori infection,
* genetic predisposition (ex: Lynch syndrome),
* MALT lymphoma,
* dyspepsia.
* Subjects affiliated with an appropriate social security system

Exclusion Criteria

* Subjects with known active cancer
* Pregnancy
* Patients receiving proton-pump inhibitors
* Conditions that may interfere with the study objectives according to the investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MATYSIAK BUDNIK Tamara, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC14_0371

Identifier Type: -

Identifier Source: org_study_id

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