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

Gastric Cancer Clinical Trial

— GASTRO-PRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624271
• Other study ID #: RC14_0371
• Status: Completed
• Phase: N/A
• Start date: August 4, 2016
• Est. completion date: May 9, 2019

Study information

• Verified date: July 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastric Precancerous Lesions
• Stomach Neoplasms

Intervention

Other:
• blood samples analysis
Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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