Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- Nantes University Hospital
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Sensitivity of GastroPanel blood test
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Sensitivity of GastroPanel blood test
Time Frame: One assessment at baseline
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.