Epidemiology, Diagnosis and Risk Factors of Helicobacter pylori Infection.
Kallirroi Kotilea, Patrick Bontems, Eliette Touati
https://pubmed.ncbi.nlm.nih.gov/31016621Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05854368
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
Led by Institut Pasteur · Updated on 2025-05-16
2500
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Institut Pasteur
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to identify and confirm a set of blood-based biomarkers in plasma that are linked to early changes in the stomach lining known as gastric preneoplasia. It compares patients who already have gastric lesions with healthy individuals. Gastric cancer is a common and serious disease worldwide, often diagnosed late due to invasive methods like endoscopy. Early detection through blood tests could improve prevention, monitoring, and treatment outcomes. The study builds on previous findings of protein signatures related to inflammation and cancer development in the stomach. Participants include patients with various gastric lesions such as glandular atrophy, intestinal metaplasia, dysplasia, and early-stage gastric adenocarcinoma, as well as healthy volunteers without stomach conditions. Blood samples of about 9 to 10 mL will be collected either during routine care or specifically for this research. The study will measure protein levels in plasma to validate and improve the prediction of early stomach changes and cancer risk across different lesion types and severities. During the study, participants will provide blood samples which will be analyzed using immuno-based methods to detect the protein signatures. Researchers will evaluate how these signatures relate to different stages of gastric lesion development over 30 months. The main outcome is to validate a protein signature associated with gastric mucosal dysplasia compared to healthy controls. Secondary outcomes include similar validations for other lesion types and cancer stages. The study involves no treatment intervention and focuses on biomarker discovery and validation.
CONDITIONS
Brief Title
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 18 years old or higher
- Written informed consent prior to any study procedure
- Affiliated to a social insurance system
- Untreated glandular atrophy (with or without intestinal metaplasia and/or dysplasia) diagnosed histologically since 2014 for patients with gastric lesions
- Treatment-naive gastric cancer (distal or proximal adenocarcinoma) for patients with gastric lesions
You will not qualify if you...
- Autoimmune disease or disease impacting the immune system (e.g., HIV)
- Chronic inflammatory disease
- Known evolutive cancer excluding gastric cancer
- Treated in the last 3 months or currently treated with therapy interfering with the immune system (e.g., immunosuppressive therapy)
- Current treatment with long-term corticosteroid therapy
- Current treatment with long-term nonsteroidal anti-inflammatory drugs
- Pregnant woman or breastfeeding
- Patient or healthy volunteer under legal protection (e.g., guardianship)
- Patient or healthy volunteer currently participating in another clinical trial evaluating an experimental medical product or device
- Patient or healthy volunteer currently in custody
- Known history of Helicobacter pylori infection for healthy volunteers
- Known history of gastric lesions for healthy volunteers (e.g., chronic gastritis, gastric atrophy, intestinal metaplasia, dysplasia, cancer)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 30 months
Participants provide blood samples to characterize and validate protein signatures associated with different stages of gastric preneoplasia and cancer.
Periodic blood collection visits during routine care or specific for research
Trial Site Locations
Total: 8 locations
1
Ambroise Paré Teaching Hospital (AP-HP)
Boulogne-Billancourt, France
Completed
2
Beaujon Teaching Hospital (AP-HP)
Clichy, France
Actively Recruiting
3
Kremlin Bicêtre Teaching Hospital (AP-HP)
Le Kremlin-Bicêtre, France
Actively Recruiting
4
Cochin Teaching Hospital (AP-HP)
Paris, France
Actively Recruiting
5
INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)
Paris, France
Actively Recruiting
6
Saint Antoine Teaching Hospital (AP-HP)
Paris, France
Actively Recruiting
7
Saint Antoine Teaching Hospital (AP-HP)
Paris, France
Not Yet Recruiting
8
Saint Louis Teaching Hospital (AP-HP)
Paris, France
Not Yet Recruiting
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Research Team
E
Eliette TOUATI, PhD
O
Olivia CHENY, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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