RecruitingNot ApplicableNCT05854368

Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

Sponsor

Institut Pasteur

Enrollment

2,500 participants

Start Date

Jul 3, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Gastric Lesion Gastric Precancerous Condition

Summary

The goal of this study is to characterize and validate a signature of circulating biomarkers in plasma, associated with the presence of gastric preneoplasia in patients with preexisting gastric lesion compared with a control group. For this purpose: * Patients with pre-existing gastric lesions will be invited to participate to this study. If they are willing to participate an additional blood sample (9 mL) will be collected at the time of the blood collection performed during their routine care * Healthy subjects will be invited to participate to constitute the control group. If they are willing to participate a blood sample (9 ml) will be drawn specifically for this study

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Common
years old or highter
written informed consent prior to any study procedure
Affiliated to a social insurance system
Specific to patients with gastric lesions
Untreated glandular atrophy (with or without intestinal metaplasia and/or dysplasia) and histologically diagnosed as of 2014
Treatment naïve Gastric cancer (distal or proximal adenocarcinoma)

Exclusion Criteria14

Common
Autoimmune disease or disease that impacts 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 that interferes 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 to a clinical trial evaluating either an experimental medical product or a medical device
Patient or healthy volunteer currently in custody
Specific to Healthy Volunteer
Known history of Helicobacter pylori infection
Known history of gastric lesions (i.e. chronic gastritis, gastric atrophy, intestinal metaplasia, dysplasia and cancer)

Interventions

PROCEDUREAdditional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care.

Collection of an additional blood volume (9 mL) as part of a blood sampling performed during routine care or specific for the research if not part of routine care.

PROCEDUREBlood collection

Blood sample collection (10 mL)