Clinical trial · Interventional
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Lesion | — | UNRESOLVED | — |
| Gastric Precancerous Condition | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care. | Procedure | — | UNRESOLVED |
| Blood collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Patients with gastric lesion
- description
- Patients with: * Gastric epithelial dysplasia * Glandular atrophy of the gastric mucosa * Intestinal metaplasia of the gastric mucosa * Proximal gastric adenocarcinoma * Distal gastric adenocarcinoma
- interventionNames
- Procedure: Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care.
- type
- OTHER
- label
- Control
- description
- Healthy Volunteers
- interventionNames
- Procedure: Blood collection
Primary outcomes (1)
- measure
- Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of gastric mucosal dysplasia lesions compared with an H. pylori negative control group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDKotilea K, Bontems P, Touati E. Epidemiology, Diagnosis and Risk Factors of Helicobacter pylori Infection. Adv Exp Med Biol. 2019;1149:17-33. doi: 10.1007/5584_2019_357. PMID 31016621