Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05854368

Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

Led by Institut Pasteur · Updated on 2025-05-16

2500

Participants Needed

8

Research Sites

126 weeks

Total Duration

On this page

Sponsors

I

Institut Pasteur

Lead Sponsor

A

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or higher
  • Written informed consent given before any study procedure
  • Affiliated with a social insurance system
  • Untreated glandular atrophy with or without intestinal metaplasia and/or dysplasia diagnosed by histology since 2014 (for patients with gastric lesions)
  • Treatment-naïve gastric cancer (distal or proximal adenocarcinoma) (for patients with gastric lesions)
Not Eligible

You will not qualify if you...

  • Autoimmune disease or disease affecting the immune system (e.g., HIV)
  • Chronic inflammatory disease
  • Known active cancer other than gastric cancer
  • Treated or currently treated within 3 months with therapy affecting the immune system (e.g., immunosuppressive therapy)
  • Current long-term corticosteroid therapy
  • Current long-term use of nonsteroidal anti-inflammatory drugs
  • Pregnant or breastfeeding women
  • Individuals under legal protection such as guardianship
  • Participation in another clinical trial involving experimental medical products or devices
  • Individuals currently in custody
  • For healthy volunteers: history of Helicobacter pylori infection
  • For healthy volunteers: history of gastric lesions including chronic gastritis, gastric atrophy, intestinal metaplasia, dysplasia, or cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Ambroise Paré Teaching Hospital (AP-HP)

Boulogne-Billancourt, France

Completed

2

Beaujon Teaching Hospital (AP-HP)

Clichy, France

Actively Recruiting

3

Kremlin Bicêtre Teaching Hospital (AP-HP)

Le Kremlin-Bicêtre, France

Actively Recruiting

4

Cochin Teaching Hospital (AP-HP)

Paris, France

Actively Recruiting

5

INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)

Paris, France

Actively Recruiting

6

Saint Antoine Teaching Hospital (AP-HP)

Paris, France

Actively Recruiting

7

Saint Antoine Teaching Hospital (AP-HP)

Paris, France

Not Yet Recruiting

8

Saint Louis Teaching Hospital (AP-HP)

Paris, France

Not Yet Recruiting

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Research Team

E

Eliette TOUATI, PhD

CONTACT

O

Olivia CHENY, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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