Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk
GASTRO-PRA
Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable gastric-cancer
Started Aug 2016
Typical duration for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedStudy Start
First participant enrolled
August 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2019
CompletedNovember 15, 2023
July 1, 2019
2.8 years
December 3, 2015
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
GastroPanel
EXPERIMENTALGastroPanel test on blood samples
Interventions
Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with known active cancer
- Pregnancy
- Patients receiving proton-pump inhibitors
- Conditions that may interfere with the study objectives according to the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nantes University Hospital
Nantes, 44093, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MATYSIAK BUDNIK Tamara, Pr
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2015
First Posted
December 8, 2015
Study Start
August 4, 2016
Primary Completion
May 9, 2019
Study Completion
May 9, 2019
Last Updated
November 15, 2023
Record last verified: 2019-07