Detecting gastric preneoplasia and cancer using blood biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Ambroise Paré Teaching Hospital (AP-HP)
  Boulogne-Billancourt, France Completed

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.