Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk (GASTRO-PRA)

November 13, 2023 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GastroPanel
GastroPanel test on blood samples
Other: blood samples analysis
Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: MATYSIAK BUDNIK Tamara, Pr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2016

Primary Completion (Actual)

May 9, 2019

Study Completion (Actual)

May 9, 2019

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimated)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0371

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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