Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT07185360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver Diseases: Extracellular Vesicles as Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 845}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decompensation Test in patients with cirrhosis', 'timeFrame': '48 months after the beginning of the project', 'description': 'The discriminating power of the Decompensation Test will be measured using the C-index'}, {'measure': 'HCC Test in patients with cirrhosis', 'timeFrame': '48 months after the beginning of the project', 'description': 'The discriminating power of the HCC Test will be measured using the C-index'}], 'secondaryOutcomes': [{'measure': 'Quantification of Extracellular vesicles proteins', 'timeFrame': '48 months after the beginning of the project', 'description': 'Number of extracellular vesicles'}, {'measure': 'Size of Extracellular vesicles proteins and the experimental repeatability', 'timeFrame': '48 months after the beginning of the project', 'description': 'size of extracellular vesicles in nm'}, {'measure': '3D morphology of extracellular vesicles', 'timeFrame': '48 months after the beginning of the project', 'description': 'size of microvesicles in nm'}, {'measure': 'Extracellular vesicles plasma concentrations in the general population', 'timeFrame': '48 months after the beginning of the project', 'description': 'Extracellular vesicles concentration per mL'}, {'measure': 'number of patients with extreme values of extracellular vesicles in the general population', 'timeFrame': '48 months after the beginning of the project', 'description': 'Extracellular vesicles concentration per mL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver decompensation', 'extracellular vesicles', 'hepatocellular carcinoma', 'cirrhosis'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Cirrhosis affects mainly a working age population, hence its heavy economic burden.While patients with compensated cirrhosis do not have symptoms and have a 10-year life expectancy, decompensation of cirrhosis heralds a dramatic decrease in life expectancy to 2 years. Biomarkers allowing reliable estimation of the risk for decompensation of cirrhosis would allow community-based care, possibly by nurse practitioners, of patients at low risk, while patients had high risk could be managed in secondary and tertiary care centers and included in clinical trials. Because HCC is usually asymptomatic at early stages, when it is still curable, it can easily be missed. Biomarkers allowing stratification of the risk of HCC would allow reinforced surveillance (using magnetic resonance imaging) of high-risk patients, and their inclusion in chemoprevention clinical trials.\n\nLIVER-TRACK aims at reliably predicting the outcome of patients with compensated cirrhosis through the development of a Tests for Decompensation and a Test for HCC. This will be achieved through leveraging circulating extracellular vesicles (EVs), an untapped source of biomarkers in liver diseases, as prognostic indicators, and combining them with existing blood biomarkers and single-nucleotide polymorphisms (SNPs). LIVER-TRACK also aims at delivering technologies for EV measurement that are useable in medical practice.', 'detailedDescription': 'Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Cirrhosis affects mainly a working age population, hence its heavy economic burden. While patients with compensated cirrhosis do not have symptoms and have a 10-year life expectancy, decompensation of cirrhosis heralds a dramatic decrease in life expectancy to 2 years. Biomarkers allowing reliable estimation of the risk for decompensation of cirrhosis would allow community-based care, possibly by nurse practitioners, of patients at low risk, while patients had high risk could be managed in secondary and tertiary care centers and included in clinical trials. Because HCC is usually asymptomatic at early stages, when it is still curable, it can easily be missed. Biomarkers allowing stratification of the risk of HCC would allow reinforced surveillance (using magnetic resonance imaging) of high-risk patients, and their inclusion in chemoprevention clinical trials.\n\nLIVER-TRACK aims at reliably predicting the outcome of patients with compensated cirrhosis through the development of a Tests for Decompensation and a Test for HCC. This will be achieved through leveraging circulating extracellular vesicles (EVs), an untapped source of biomarkers in liver diseases, as prognostic indicators, and combining them with existing blood biomarkers and single-nucleotide polymorphisms (SNPs). LIVER-TRACK also aims at delivering technologies for EV measurement that are useable in medical practice.\n\nLIVER-TRACK outputs are expected to: i) improve care for individual patients at highest medical need, i.e., patients with cirrhosis with high risk of decompensation or HCC; ii) decrease cirrhosis burden for public health, iii) facilitate drug development; and iv) technically allow exploitation of EVs as biomarkers in clinical practice, an obligatory step permitting expansion to other fields such as cancer and cardiovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Volunteers without liver disease\n\n\\- Inclusion criteria: Major\n\nExclusion Criteria:\n\n* Known liver disease\n* Active cancer\n* Viral or bacterial infection within 2 weeks of inclusion (respiratory, dermatological, urinary, digestive, etc.)\n* Transfusion in the month preceding inclusion\n* Current participation or less than 3 months' participation in a therapeutic interventional trial\n* Absence of signed informed consent\n* Not affiliated to a social security scheme\n* Pregnant women\n* Person under guardianship or trusteeship\n\nDiabetic patients with F3/F4 fibrosis recruited and followed prospectively\n\nInclusion criteria:\n\n* Patient aged 18 or over\n* Type 2 diabetic (ADA/WHO criteria recalled in section 20.5)\n* Hepatic fibrosis stage F3/F4 on liver biopsy or hepatic elasticity \\> 10 kPa\n\nExclusion criteria:\n\nVulnerable person: a person deprived of liberty by a judicial or administrative decision, or under psychiatric care, and a person admitted to a health or social institution for purposes other than research.\n\n* Protected adult\n* Not affiliated to or not benefiting from a social security scheme\n* Pregnant or breast-feeding women\n* Absence of signed informed consent\n* Illness linked to other etiologies:\n\n * Alcoholic liver disease\n * Current hepatitis B virus infection\n * Current hepatitis C virus infection\n * Autoimmune hepatitis according to according to AASLD and EASL recommended criteria\n * Transferrin saturation \\>50%\n * Alpha antitrypsin ZZ or SZ type deficiency\n * Wilson's disease\n * Liver transplant patients\n * Ultrasound obstruction of blood vessels or bile ducts (on routine ultrasound). If nothing is mentioned on the report, it is considered that there is no obstruction of the blood vessels or bile ducts).\n* Current participation or less than 3 months' participation in a therapeutic interventional trial\n\nPatients with liver disease :\n\nInclusion criteria:\n\n* Major\n* Child-Pugh A, B or C cirrhosis, diagnosed on the basis of histological evidence or liver elasticity \\> 15 kPa or a combination of biological and radiological signs.\n\nExclusion criteria:\n\n* Presence of one of the following diseases in the 15 days prior to inclusion: acute renal failure, bacterial infection (proven or suspected on clinico-biological criteria), digestive bleeding,\n* alcoholic hepatitis in the month prior to inclusion\n* Previous porto-systemic shunt, liver transplantation, primary sclerosing cholangitis, primary biliary cholangitis, Budd-Chiari syndrome\n* Active or past hepatocellular carcinoma\n* Active extrahepatic neoplasia,\n* Current participation or less than 3 months' participation in a therapeutic interventional trial\n* Absence of signed informed consent\n* Non affiliation to a social security scheme\n* Pregnant or breast-feeding\n* Person under guardianship or trusteeship"}, 'identificationModule': {'nctId': 'NCT07185360', 'acronym': 'LIVER-TRACK', 'briefTitle': 'Liver Diseases: Extracellular Vesicles as Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Liver Diseases: Extracellular Vesicles as Biomarkers', 'orgStudyIdInfo': {'id': 'APHP250409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Volunteers without liver disease', 'description': 'Volunteers without liver disease', 'interventionNames': ['Other: blood sampling for volunteers']}, {'type': 'OTHER', 'label': 'Diabetic patients with F3/F4 fibrosis recruited and followed prospectively', 'description': 'Diabetic patients with F3/F4 fibrosis recruited and followed prospectively', 'interventionNames': ['Other: blood sampling for diabetics patients with F3/F4 fibrosis']}, {'type': 'OTHER', 'label': 'Patients with liver disease', 'description': 'Patients with liver disease', 'interventionNames': ['Other: blood sampling for patients with liver disease']}], 'interventions': [{'name': 'blood sampling for volunteers', 'type': 'OTHER', 'description': 'A 38.5 ml blood sample will be taken to test for research taken to test for research', 'armGroupLabels': ['Volunteers without liver disease']}, {'name': 'blood sampling for diabetics patients with F3/F4 fibrosis', 'type': 'OTHER', 'description': '32.5 ml will be sampled at inclusion, at one year visit and two year visit', 'armGroupLabels': ['Diabetic patients with F3/F4 fibrosis recruited and followed prospectively']}, {'name': 'blood sampling for patients with liver disease', 'type': 'OTHER', 'description': 'A blood sample of 35.5 mL maximum will be taken for research purposes at the inclusion visit, M1 visit and M3 visit.', 'armGroupLabels': ['Patients with liver disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'state': 'France', 'country': 'France', 'contacts': [{'name': 'Pierre Emmanuel RAUTOU', 'role': 'CONTACT', 'email': 'pierre-emmanuel.rautou@aphp.fr', 'phone': '+33 1 40 87 52 83'}], 'facility': 'Bichat Hospital, Beaujon Hospital, Cochin Hospital and Lariboisière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Pierre Emmanuel RAUTOU', 'role': 'CONTACT', 'email': 'pierre-emmanuel.rautou@aphp.fr', 'phone': '+33 1 40 87 52 83'}], 'overallOfficials': [{'name': 'Pierre Emmanuel RAUTOU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}