Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

NCT ID: NCT05854368

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2025-12-31

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

Detailed Description

Gastric cancer (GC) is the fourth cause of cancer-related death and the fifth most common diagnosed cancer worldwide with 1 million new cases per year. GC is mainly associated with a poor prognosis, highlighting the importance of its early detection. GC results from a multistep process starting from a gastric chronic inflammation preceding atrophic gastritis (AG), the development of preneoplasia (intestinal metaplasia (IM), dysplasia (Dys) and then cancer lesions. Presently, GC can only be diagnosed by endoscopy, which is an invasive, and costly method with its limits. Indeed, preneoplasia as Dys can escape endoscopic detection. Therefore, the discovery of blood-based biomarkers to identify the presence of gastric preneoplasia and/or cancer lesions at the earliest, at an asymptomatic stage, is of paramount interest. It is crucial not only for the early detection/prevention of individuals at risk of GC but also useful for patient follow-up to predict disease recurrence/outcome and to monitor treatment. Using plasma samples from patients at various stages of the GC cascade, we previously identified two signatures of 6 protein candidates to predict the presence of preneoplasia and GC lesions. Based on these data, the goal of this study is to further test and validate these different signatures, and to improve their predictive ability at the earliest stages of the GC cascade, taking into account the different types of gastric preneoplasia, IM and Dys, and their grade of severity. To achieve this goal, a large multicentric cohort of patients will be established including different groups of plasma samples covering the most complete panel of the type/grades of gastric preneoplasia as well as at early stages of GC. These plasma samples will be then used to measure the level of the different signature components using various method of analysis as immuno-based assays.

Conditions

Gastric Lesion; Gastric Precancerous Condition; Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with gastric lesion

Patients with:

• Gastric epithelial dysplasia
• Glandular atrophy of the gastric mucosa
• Intestinal metaplasia of the gastric mucosa
• Proximal gastric adenocarcinoma
• Distal gastric adenocarcinoma

Group Type: OTHER

Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care.

Intervention Type: 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.

Control

Healthy Volunteers

Group Type: OTHER

Blood collection

Intervention Type: PROCEDURE

Blood sample collection (10 mL)

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.

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.

Intervention Type: PROCEDURE

Blood collection

Blood sample collection (10 mL)

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique LAMARQUE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ambroise Paré Teaching Hospital (AP-HP)

Locations

Ambroise Paré Teaching Hospital (AP-HP)

Boulogne-Billancourt, , France

Site Status: COMPLETED

Beaujon Teaching Hospital (AP-HP)

Clichy, , France

Site Status: RECRUITING

Kremlin Bicêtre Teaching Hospital (AP-HP)

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

Cochin Teaching Hospital (AP-HP)

Paris, , France

Site Status: RECRUITING

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

Paris, , France

Site Status: RECRUITING

Saint Antoine Teaching Hospital (AP-HP)

Paris, , France

Site Status: RECRUITING

Saint Antoine Teaching Hospital (AP-HP)

Paris, , France

Site Status: NOT_YET_RECRUITING

Saint Louis Teaching Hospital (AP-HP)

Paris, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Eliette TOUATI, PhD

Role: CONTACT

eliette.touati@pasteur.fr

+33140613785

Olivia CHENY, PhD

Role: CONTACT

olivia.cheny@pasteur.fr

Facility Contacts

Frédéric PRAT, MD, PhD

Role: primary

Aurélien AMIOT, MD, PhD

Role: primary

Romain CORIAT, MD, PhD

Role: primary

Hélène LAUDE, MD

Role: primary

Xavier DRAY, MD, PhD

Role: primary

Thibault VORON, MD, MCU-PH

Role: primary

thibault.voron@aphp.fr

+33 1 49 28 25 47

Pierre CATTAN, Pr

Role: primary

pierre.cattan@aphp.fr

+33 1 42 49 93 81

References

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.

Reference Type: BACKGROUND

PMID: 31016621 (View on PubMed)

Other Identifiers

2021-097

Identifier Type: -

Identifier Source: org_study_id