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

Not Applicable

Completed

• Conditions: Gastric Precancerous Lesions; Gastric Cancer
• Interventions: Other: blood samples analysis

• Registration Number: NCT02624271
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Study Start: 2016-08-04
• Primary Completion: 2019-05-09
• Study Completion: 2019-05-09
• Status Verified: 2019-07
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GastroPanel	blood samples analysis	GastroPanel test on blood samples

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France