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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric Precancerous Lesions Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples analysis

Other

Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.

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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: GASTRO-PRA

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Dec 8, 2015
Registry last updated: Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed