Gastric Cancer, Gastric Precancerous Lesions
Conditions
Keywords
gastric cancer, gastric precancerous lesions, blood test
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.
Interventions
Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of GastroPanel blood test | 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. |
Countries
France
Outcome results
None listed