Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT06774768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2025-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'All enrolled patients will receive additional blood sampling at enrolment (approximately 20 ml) and then at 6 and 12 month of follow-up, during a venopucture performed for the standard laboratory follow-up. Additional samples will be used for assaying a comprehensive array of biomarkers that may provide information regarding immune system activity (T-regs, circulating nanovescicles, microRNA), graft injury (donor-derived cell free DNA), and susceptibility to infection (Quantiferon Monitor; Torque Teno Virus).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection', 'timeFrame': '4 years', 'description': 'Infection, defined as systemic or organ-specific syndrome characterized by evidence of inflammatory response, abnormal organ function, and need for intravenous antimicrobial treatment, with or without microbiological isolate.'}, {'measure': 'Major Cardiovascular Event (MACE)', 'timeFrame': '4 years', 'description': 'Major Cardiovascular Event (MACE) defined as, fatal or non-fatal myocardial infarction, ischemic or hemorrhagic stroke, admission for heart failure, new onset arrhythmia, new onset symptoms for peripheral artery diseases'}, {'measure': 'New onset malignancy', 'timeFrame': '4 years', 'description': 'New onset malignancy, defined as hematopoietic or solid malignant neoplasm, developing after transplantation'}, {'measure': 'Chronic graft dysfunction', 'timeFrame': '4 years', 'description': 'Chronic graft dysfunction; in HTX recipients defined as onset of one or more of the following: CAV grade 2 or greater as diagnosed by standard of care coronary angiography; diffuse fibrosis with signs of diastolic or systolic left ventricle dysfunction. In LTX we define chronic graft dysfunction as progressive fibrosis, cholestasis and reduced protein synthesis, portal hypertension.'}], 'secondaryOutcomes': [{'measure': 'ML-Scores as Surrogate Endpoints', 'timeFrame': '4 years', 'description': 'The ML-scores developed to predict the primary outcomes will be used as secondary study outcomes for the prospective phase of the study, and will be tested as surrogate endpoints for clinical outcomes. In this approach, we will analyze the association between such defined surrogate endpoints and biomarkers, QoL and cognitive scores, and frailty measurements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Intelligence (AI)', 'Hepatocellular Carcinoma (HCC)', 'Heart Transplantation', 'Liver Transplantation', 'Machine Learning', 'Major Cardiovascular Event']}, 'descriptionModule': {'briefSummary': 'This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO).\n\nThis clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.', 'detailedDescription': 'This study is structured in two phases: 1) a retrospective phase that aims to develop ML-based scores that can allow to predict at patient level the risk of infections, cardiovascular diseases, new onset malignancies and chronic graft dysfunction, and describing the trajectory of this risk over time; 2) a prospective phase in which we test the association of biomarkers, QoL and frailty assessments with the ML-scores applied prospectively in heart and liver transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In the retrospective phase we will include all patients receiving heart or liver transplantation between January 2008 and December 2020 and surviving at least 6 months after surgery.\n\nIn the prospective phase we will consider for enrolment all patients with heart or liver transplantation actively on follow-up at IRCCS AOUBO from January 2024 and January 2026.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Retrospective cohort Inclusion criteria Receiving a heart or liver transplantation at IRCCS AOUBO between January 2008 and December 2020.\n\nSurviving at least 6 months after surgery Receiving at least one outpatient clinical assessment, comprising clinical evaluation, standard laboratory tests, and graft ultrasound Older than 18 years old\n\nExclusion criteria Unavailability of medical records in the standard data repositories of IRCCS AOUBO\n\nProspective cohort\n\nInclusion criteria Older thant 18 years old Receiving a heart or liver transplantation at least 6 months before study entry and being in active follow up at IRCCS AOUBO Obtaining informed consent\n\nExclusion criteria None'}, 'identificationModule': {'nctId': 'NCT06774768', 'acronym': 'DARE', 'briefTitle': 'Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients', 'orgStudyIdInfo': {'id': 'DARE'}, 'secondaryIdInfos': [{'id': 'PNC0000002 3000435', 'type': 'OTHER_GRANT', 'domain': 'Bando PNRR - Ministero della Salute'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'contacts': [{'name': 'Luciano Potena, MD', 'role': 'CONTACT', 'email': 'scompenso.trapiantocuore@aosp.bo.it', 'phone': '0512143725'}], 'facility': 'IRCCS - Azienda ospedaliero-universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'contacts': [{'name': 'Maria Cristina Morelli, MD', 'role': 'CONTACT', 'email': 'mariacristina.morelli@aosp.bo.it', 'phone': '0512144248'}], 'facility': 'IRCCS - Azienda ospedaliero-universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Luciano Potena, MD', 'role': 'CONTACT', 'email': 'scompenso.trapiantocuore@aosp.bo.it', 'phone': '0512143725'}], 'overallOfficials': [{'name': 'Luciano Potena, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}