Gastric LesionPREGASIGN#1NCT05854368
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
A study testing Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care. and Blood collection in people with Gastric Lesion and Gastric Precancerous Condition, run by Institut Pasteur at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Lesion, Gastric Precancerous Condition, Gastric Cancer
- What is being tested?
- Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care. and Blood collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 8 sitesFrance
- Study dates
- 3 Jul 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Olivia CHENY, PhD contact
8 sites in 1 country
France8 sites, 7 recruiting
- Completed
Ambroise Paré Teaching Hospital (AP-HP)
Boulogne-Billancourt
- Recruiting
Beaujon Teaching Hospital (AP-HP)
Clichy
Frédéric PRAT, MD, PhD
- Recruiting
Kremlin Bicêtre Teaching Hospital (AP-HP)
Le Kremlin-Bicêtre
Aurélien AMIOT, MD, PhD
- Recruiting
Cochin Teaching Hospital (AP-HP)
Paris
Romain CORIAT, MD, PhD
- Recruiting
INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)
Paris
Hélène LAUDE, MD
- Recruiting
Saint Antoine Teaching Hospital (AP-HP)
Paris
Xavier DRAY, MD, PhD
- Not yet recruiting
Saint Antoine Teaching Hospital (AP-HP)
Paris
Thibault VORON, MD, MCU-PH, +33 1 49 28 25 47, thibault.voron@aphp.fr
- Not yet recruiting
Saint Louis Teaching Hospital (AP-HP)
Paris
Pierre CATTAN, Pr, +33 1 42 49 93 81, pierre.cattan@aphp.fr
About this study
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
Read the 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.
- Being tested
- Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care., Blood collection
- Keywords
- Gastric Cancer, biomarkers,
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
Blood collectionProcedure or surgery
Blood sample collection (10 mL)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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).
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start3 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric LesionStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with gastric lesion (including preneoplasia or cancer) and Healthy Volunteers (control)
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Dominique LAMARQUE, MD, PhD, Principal investigator, Ambroise Paré Teaching Hospital (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854368
- Sponsor's protocol ID
- 2021-097
- Acronym
- PREGASIGN#1
- Status last verified
- May 2025
- First submitted
- 8 Feb 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31016621
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
- ClinicalTrials.gov ID
- NCT05854368
- Acronym / sponsor ID
- PREGASIGN#1 / 2021-097
- Keywords
- Gastric Cancer, biomarkers,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with gastric lesion (including preneoplasia or cancer) and Healthy Volunteers (control)
| Arm | Type | Receives |
|---|---|---|
| Patients with gastric lesion | Other | 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.Patients with: * Gastric epithelial dysplasia * Glandular atrophy of the gastric mucosa * Intestinal metaplasia of the gastric mucosa * Proximal gastric adenocarcinoma * Distal gastric adenocarcinoma |
| Control | Other | Procedure: Blood collectionHealthy Volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients with gastric lesion |
| Blood collectionBlood sample collection (10 mL) | Procedure or surgery | Control |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 31016621Kotilea 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia CHENY, PhD contact
Dominique LAMARQUE, MD, PhD principal investigator
Ambroise Paré Teaching Hospital (AP-HP)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care. and Blood collection in people with Gastric Lesion and Gastric Precancerous Condition, run by Institut Pasteur at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliette TOUATI, PhD (+33140613785, eliette.touati@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.