Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 2:33 PM
Study NCT ID:
NCT03825458
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma EDTA and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2029-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of plot samples collected', 'timeFrame': 'maximum 46 months', 'description': 'The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study).\n\nThis cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible)\n* Patients requiring blood sampling for medical care at the time of the medical appointment.\n* Informed patients who do not refuse to participate.\n* Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study\n\nExclusion Criteria:\n\n* Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study.\n* Persons deprived of their liberty by a judicial or administrative decision\n* Adults who are subject to a legal protection measure\n* Children less than 6 years old (in Lyon)'}, 'identificationModule': {'nctId': 'NCT03825458', 'acronym': 'CirB-RNA', 'briefTitle': 'Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.', 'orgStudyIdInfo': {'id': '69HCL18_0436'}, 'secondaryIdInfos': [{'id': '2018-A02558-47', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling at each clinical follow-up visit.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien ZOULIM, Pr', 'role': 'CONTACT', 'email': 'fabien.zoulim@chu-lyon.fr', 'phone': '04 26 10 93 55', 'phoneExt': '+33'}], 'facility': 'Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69317', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick MIAILHES, MD, PhD', 'role': 'CONTACT', 'email': 'patrick.miailhes@chu-lyon.fr', 'phone': '04 26 73 26 58', 'phoneExt': '+33'}, {'name': 'Patrick MIAILHES, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69677', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Noémie Laverdure, MD, PhD', 'role': 'CONTACT', 'email': 'noemie.laverdure@chu-lyon.fr', 'phone': '4 72 12 94 34', 'phoneExt': '+33'}], 'facility': 'Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro LAMPERTICO, Pr', 'role': 'CONTACT', 'email': 'pietro.lampertico@unimi.it', 'phone': '0255035432', 'phoneExt': '+39'}], 'facility': "Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '90133', 'city': 'Palermo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio CRAXI, Pr', 'role': 'CONTACT', 'email': 'antonio.craxi@unipa.it'}], 'facility': 'Gastroenterology and Hepatology department - • Università degli Studi di Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '43126', 'city': 'Parma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo FERRARI, Pr', 'role': 'CONTACT', 'email': 'cferrari00@gmail.com', 'phone': '0521702762', 'phoneExt': '+39'}], 'facility': 'Infectious diseases and hepatology unit - Azienda Ospedaliero', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'centralContacts': [{'name': 'Fabien ZOULIM, Pr', 'role': 'CONTACT', 'email': 'fabien.zoulim@chu-lyon.fr', 'phone': '04 26 10 93 55', 'phoneExt': '+33'}, {'name': 'Massimo LEVERO, Pr', 'role': 'CONTACT', 'email': 'massimo.levrero@inserm.fr', 'phone': '04 72 68 19 79', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}