Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-01 @ 8:54 AM
Study NCT ID:
NCT06679257
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2024-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081182', 'term': 'Noninvasive Prenatal Testing'}], 'ancestors': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011296', 'term': 'Prenatal Diagnosis'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cell free DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Damage distinction', 'timeFrame': 'One month, three months, one year, three years, five years', 'description': 'Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.'}], 'secondaryOutcomes': [{'measure': 'Damage detection Limit', 'timeFrame': 'One month, three months, one year, three years, five years', 'description': 'If the null hypothesis is disproven, measure optimal cut off for distincition beteween samples indicating damage and not indicating damage. Also distinction between different types of damage, finally if distinction is attainable trhough association wit other known biomarkers.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant Failure and Rejection', 'Lung Transplant Infection']}, 'descriptionModule': {'briefSummary': "LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this.\n\nThe current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. The specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after LTx. An in-house-developed PCR-based cell-free-DNA methodology (cf-DNA) will be used for allograft damage and combined with specific other biomarkers to identify damage type. The current clinical golden standard for damage identification will be performed at every sampling instance.\n\nThe research will be a single-centre prospective observational cohort study. The control samples at all time points will consist of the samples without allograft damage. Blood will be drawn at fixed time points and clinical events. All analyses will be performed at a separate lab, blinded to the patient's status.\n\n."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly lung transplanted patients within scandinavia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Luing Transplanted and followed up within the reach of the study paricipating centres.\n\nA good understanding to read and write within the languages in which the consent is provided.\n\nExclusion Criteria:\n\n* Not Lung Transplanted or not followed up within the reach of the study paricipating centres.\n\nNo good understanding to read and write within the languages in which the consent is provided.'}, 'identificationModule': {'nctId': 'NCT06679257', 'acronym': 'LEONARDO', 'briefTitle': 'Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Liquid Biopsies for Lung Allograft Damage Classification', 'orgStudyIdInfo': {'id': 'LEONARDO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung transplanted patients', 'description': 'All eligible patients were transplanted and followed up within the catchment area of the participating centre.', 'interventionNames': ['Diagnostic Test: cell-free dNA']}], 'interventions': [{'name': 'cell-free dNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients', 'armGroupLabels': ['Lung transplanted patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jesper M Magnusson, MD, PhD', 'role': 'CONTACT', 'email': 'jesper.magusson@gu.se', 'phone': '+046313421000'}], 'facility': 'Sahlgrenska University hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Jesper M Magnusson, MD, PhD', 'role': 'CONTACT', 'email': 'jesper.magnusson@gu.se', 'phone': '+0463421000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jesper Magnusson', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate professor', 'investigatorFullName': 'Jesper Magnusson', 'investigatorAffiliation': 'Vastra Gotaland Region'}}}}