Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 9:27 PM
Study NCT ID:
NCT05854368
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2023-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with gastric lesion (including preneoplasia or cancer) and Healthy Volunteers (control)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '30 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '30 months', 'description': '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.'}, {'measure': '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.', 'timeFrame': '30 months', 'description': '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.'}, {'measure': '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.', 'timeFrame': '30 months', 'description': '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.'}, {'measure': '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.', 'timeFrame': '30 months', 'description': '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.'}, {'measure': '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', 'timeFrame': '30 months', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer, biomarkers,'], 'conditions': ['Gastric Lesion', 'Gastric Precancerous Condition', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '31016621', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nFor this purpose:\n\n* 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\n* 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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCommon\n\n* 18 years old or highter\n* written informed consent prior to any study procedure\n* Affiliated to a social insurance system\n\nSpecific to patients with gastric lesions\n\n* Untreated glandular atrophy (with or without intestinal metaplasia and/or dysplasia) and histologically diagnosed as of 2014\n* Treatment naïve Gastric cancer (distal or proximal adenocarcinoma)\n\nExclusion Criteria:\n\nCommon\n\n* Autoimmune disease or disease that impacts the immune system (e.g: HIV)\n* Chronic inflammatory disease\n* Known evolutive cancer (excluding gastric cancer)\n* Treated in the last 3 months or currently treated with therapy that interferes with the immune system (e.g. immunosuppressive therapy)\n* Current treatment with long-term corticosteroid therapy\n* Current treatment with long-term nonsteroidal anti-inflammatory drugs\n* Pregnant woman or breastfeeding\n* Patient or healthy volunteer under legal protection (e.g. guardianship)\n* Patient or healthy volunteer currently participating to a clinical trial evaluating either an experimental medical product or a medical device\n* Patient or healthy volunteer currently in custody\n\nSpecific to Healthy Volunteer\n\n* Known history of Helicobacter pylori infection\n* Known history of gastric lesions (i.e. chronic gastritis, gastric atrophy, intestinal metaplasia, dysplasia and cancer)'}, 'identificationModule': {'nctId': 'NCT05854368', 'acronym': 'PREGASIGN#1', 'briefTitle': 'Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Pasteur'}, 'officialTitle': 'Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer', 'orgStudyIdInfo': {'id': '2021-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with gastric lesion', 'description': 'Patients with:\n\n* Gastric epithelial dysplasia\n* Glandular atrophy of the gastric mucosa\n* Intestinal metaplasia of the gastric mucosa\n* Proximal gastric adenocarcinoma\n* Distal gastric adenocarcinoma', 'interventionNames': ['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.']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Healthy Volunteers', 'interventionNames': ['Procedure: Blood collection']}], 'interventions': [{'name': 'Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care.', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Patients with gastric lesion']}, {'name': 'Blood collection', 'type': 'PROCEDURE', 'description': 'Blood sample collection (10 mL)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boulogne-Billancourt', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Ambroise Paré Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'city': 'Clichy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric PRAT, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Beaujon Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien AMIOT, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Kremlin Bicêtre Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain CORIAT, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Cochin Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène LAUDE, MD', 'role': 'CONTACT'}], 'facility': 'INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier DRAY, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Saint Antoine Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibault VORON, MD, MCU-PH', 'role': 'CONTACT', 'email': 'thibault.voron@aphp.fr', 'phone': '+33 1 49 28 25 47'}], 'facility': 'Saint Antoine Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre CATTAN, Pr', 'role': 'CONTACT', 'email': 'pierre.cattan@aphp.fr', 'phone': '+33 1 42 49 93 81'}], 'facility': 'Saint Louis Teaching Hospital (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Eliette TOUATI, PhD', 'role': 'CONTACT', 'email': 'eliette.touati@pasteur.fr', 'phone': '+33140613785'}, {'name': 'Olivia CHENY, PhD', 'role': 'CONTACT', 'email': 'olivia.cheny@pasteur.fr'}], 'overallOfficials': [{'name': 'Dominique LAMARQUE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ambroise Paré Teaching Hospital (AP-HP)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}