Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer (PREGASIGN#1)

May 13, 2025 updated by: Institut Pasteur

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Boulogne-Billancourt, France
        • Completed
        • Ambroise Paré Teaching Hospital (AP-HP)
      • Clichy, France
        • Recruiting
        • Beaujon Teaching Hospital (AP-HP)
        • Contact:
          • Frédéric PRAT, MD, PhD
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Kremlin Bicêtre Teaching Hospital (AP-HP)
        • Contact:
          • Aurélien AMIOT, MD, PhD
      • Paris, France
        • Not yet recruiting
        • Saint Antoine Teaching Hospital (AP-HP)
        • Contact:
      • Paris, France
        • Recruiting
        • Cochin Teaching Hospital (AP-HP)
        • Contact:
          • Romain CORIAT, MD, PhD
      • Paris, France
        • Recruiting
        • INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)
        • Contact:
          • Hélène LAUDE, MD
      • Paris, France
        • Recruiting
        • Saint Antoine Teaching Hospital (AP-HP)
        • Contact:
          • Xavier DRAY, MD, PhD
      • Paris, France
        • Not yet recruiting
        • Saint Louis Teaching Hospital (AP-HP)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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
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.
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.
Other: Control
Healthy Volunteers
Procedure: Blood collection
Blood sample collection (10 mL)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 months
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of glandular atrophy lesions 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 gastric glandular atrophy lesions will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a 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.
Time Frame: 30 months
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of intestinal metaplastic lesions within 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 gastric intestinal metaplastic lesions will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a 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.
Time Frame: 30 months
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of proximal gastric adenocarcinoma 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 proximal gastric adenocarcinoma will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a 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.
Time Frame: 30 months
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of distal gastric adenocarcinoma 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 distal gastric adenocarcinoma will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a 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
Time Frame: 30 months
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of gastric lesions at the different stages of the gastric cancer cascade (dysplasia, glandular atrophy, intestinal metaplasia, proximal gastric adenocarcinoma and distal gastric adenocarcinoma), 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 plasma levels will be compared between patients from the different groups of gastric lesions dysplasia, glandular atrophy, intestinal metaplasia, proximal gastric adenocarcinoma and distal gastric adenocarcinoma).
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Pasteur

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominique LAMARQUE, MD, PhD, Ambroise Paré Teaching Hospital (AP-HP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-097

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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