Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
Recruiting now · Not applicable
Conditions studied: Gastric Lesion, Gastric Precancerous Condition, Gastric Cancer
In brief
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
Key facts
- Study ID
- NCT05854368
- Run by
- Institut Pasteur
- People needed
- 2500
- Starts
- 2023-07-03
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Common
- 18 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)
You may not qualify if…
- 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)
Where it is running
- Saint Antoine Teaching Hospital (AP-HP) — Paris, France (enrolling)
- Beaujon Teaching Hospital (AP-HP) — Clichy, France (enrolling)
- Kremlin Bicêtre Teaching Hospital (AP-HP) — Le Kremlin-Bicêtre, France (enrolling)
- Cochin Teaching Hospital (AP-HP) — Paris, France (enrolling)
- INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur) — Paris, France (enrolling)
- Saint Louis Teaching Hospital (AP-HP) — Paris, France
- Saint Antoine Teaching Hospital (AP-HP) — Paris, France
- Ambroise Paré Teaching Hospital (AP-HP) — Boulogne-Billancourt, France
Full record on ClinicalTrials.gov
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