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

Study Overview
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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.

Official Title
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Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study

Conditions
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Gastric Cancer, Gastric Precancerous Lesions

Intervention / Treatment
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* Other: blood samples analysis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GastroPanel<br>GastroPanel test on blood samples | Other: blood samples analysis<br>* Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of GastroPanel blood test | The pepsinogen I (PGI) level measure will be compared with the gold standard method (anatomopathological examination of gastric biopsy). Results will be expressed in accordance with Sydney system. Patients will be classified as ill if PGI<30µg/l, healthy if PGI >=30µg/l. The sensitivity of GastroPanel test will be calculated with their 95% confidence interval. | One assessment at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood test, gastric cancer, gastric precancerous lesions