Detecting gastric preneoplasia and cancer using blood biomarkers
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
NA · Institut Pasteur · NCT05854368
This study is testing whether certain blood markers can help find early signs of stomach cancer in people with existing stomach problems and healthy individuals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Pasteur (industry) |
| Locations | 8 sites (Boulogne-Billancourt and 7 other locations) |
| Trial ID | NCT05854368 on ClinicalTrials.gov |
What this trial studies
This study aims to identify and validate a set of circulating biomarkers in plasma that are associated with gastric preneoplasia in patients who have pre-existing gastric lesions. Participants will include patients with untreated gastric lesions and healthy individuals who will serve as a control group. Blood samples will be collected from both groups to analyze the presence of specific biomarkers that may indicate early stages of gastric cancer. The goal is to improve early detection methods for gastric cancer, which is currently reliant on invasive procedures like endoscopy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with untreated gastric lesions or treatment-naïve gastric cancer.
Not a fit: Patients with autoimmune diseases, chronic inflammatory diseases, or those currently undergoing treatment that affects the immune system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive blood test for the early detection of gastric cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using blood-based biomarkers for cancer detection, but this specific approach is novel in the context of gastric preneoplasia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 this trial is running
Boulogne-Billancourt and 7 other locations
- Ambroise Paré Teaching Hospital (AP-HP) — Boulogne-Billancourt, France (COMPLETED)
- Beaujon Teaching Hospital (AP-HP) — Clichy, France (RECRUITING)
- Kremlin Bicêtre Teaching Hospital (AP-HP) — Le Kremlin-Bicêtre, France (RECRUITING)
- Cochin Teaching Hospital (AP-HP) — Paris, France (RECRUITING)
- INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur) — Paris, France (RECRUITING)
- Saint Antoine Teaching Hospital (AP-HP) — Paris, France (RECRUITING)
- Saint Antoine Teaching Hospital (AP-HP) — Paris, France (NOT_YET_RECRUITING)
- Saint Louis Teaching Hospital (AP-HP) — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Dominique LAMARQUE, MD, PhD — Ambroise Paré Teaching Hospital (AP-HP)
- Study coordinator: Eliette TOUATI, PhD
- Email: eliette.touati@pasteur.fr
- Phone: +33140613785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Lesion, Gastric Precancerous Condition, Gastric Cancer, Gastric Cancer, biomarkers,