Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

NCT05854368 | Recruiting

• 1 other identifier: 2021-097
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 8

Brief Summary

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

Gastric Lesion; Gastric Precancerous Condition; Gastric Cancer

Keywords

Gastric Cancer, biomarkers,

Outcome Measures

Primary Outcomes (1)

• 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.

  From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of dysplasia in the gastric mucosa and that have signed a prior consent form, the concentration of protein biomarker candidates will be determined using a bead-based immunoassay according to Luminex® technology. It will be expressed as amount per ml of plasma. For each protein constituting the signature of biomarkers, its levels in the plasma of patients with dysplasia will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a control group.

  30 months

Secondary Outcomes (5)

• Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of glandular atrophy lesions compared with an H. pylori negative control group.

  30 months

• Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of intestinal metaplastic lesions compared with an H. pylori negative control group.

  30 months

• Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of proximal gastric adenocarcinoma compared with an H. pylori negative control group.

  30 months

• Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of distal gastric adenocarcinoma compared with an H. pylori negative control group.

  30 months

• Characterization of the plasma levels of the proteins biomarker composing these signatures specific for the different stages of gastric cancer cascade, between the different studied pathology groups

  30 months

Study Arms (2)

Patients with gastric lesion

OTHER

Patients with: * Gastric epithelial dysplasia * Glandular atrophy of the gastric mucosa * Intestinal metaplasia of the gastric mucosa * Proximal gastric adenocarcinoma * Distal gastric adenocarcinoma

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.

Control

OTHER

Healthy Volunteers

Procedure: Blood collection

Interventions

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

Collection of an additional blood volume (9 mL) as part of a blood sampling performed during routine care or specific for the research if not part of routine care.

Patients with gastric lesion

Blood collection PROCEDURE

Blood sample collection (10 mL)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Common
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut Pasteur: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (8)

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

Related Publications (1)

• Kotilea 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 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dominique LAMARQUE, MD, PhD

  Ambroise Paré Teaching Hospital (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliette TOUATI, PhD

CONTACT

+33140613785; eliette.touati@pasteur.fr

Olivia CHENY, PhD

CONTACT

olivia.cheny@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with gastric lesion (including preneoplasia or cancer) and Healthy Volunteers (control)

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: May 11, 2023
• Study Start: July 3, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

FR (8)