NCT05854368Recruiting
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 8 Feb 2023
- Start date
- 3 Jul 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Institut Pasteur
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05854368
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From 3 Jul 2023 to the primary completion date, Dec 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Autoimmune disease or disease that impacts the immune system (e.g: HIV)
- Chronic inflammatory disease
- Known evolutive cancer (excluding gastric cancer)
- Known history of Helicobacter pylori infection
- Known history of gastric lesions (i.e. chronic gastritis, gastric atrophy, intestinal metaplasia, dysplasia and cancer)
Other
- Common
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ambroise Paré Teaching Hospital (AP-HP) Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Completed |
| Beaujon Teaching Hospital (AP-HP) Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Kremlin Bicêtre Teaching Hospital (AP-HP) Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Cochin Teaching Hospital (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Saint Antoine Teaching Hospital (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Saint Louis Teaching Hospital (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.