Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT06494033
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive CMV Immunoglobulin (IgG) positive lung transplant', 'timeFrame': 'Up to 1 year', 'description': 'Positive CMV Immunoglobulin (IgG) measured by IU/ml'}], 'secondaryOutcomes': [{'measure': 'Graft Outcome status', 'timeFrame': 'Up to 1 year', 'description': 'Graft Outcome status measured by number of rejection based on forced expiratory volume in 1 second( FEV1) /Forced vital capacity (FVC) ratio. A calculated ratio that helps diagnose obstructive and restrictive lung diseases'}, {'measure': 'Number of dead participants', 'timeFrame': 'Up to 1 year', 'description': 'Number of dead participants measured by numbers of death'}, {'measure': 'Duration of CMV medication', 'timeFrame': 'Up to 1 year', 'description': 'Duration of CMV medication measured by treatment days'}, {'measure': 'Number of patients with CMV-positive results', 'timeFrame': 'Up to 1 year', 'description': 'CMV disease measured by the number of patients with CMV-positive results'}, {'measure': 'Severity of CMV Disease', 'timeFrame': 'Up to 1 year', 'description': 'Severity of CMV disease measured by CMV polymerase chain reaction (PCR) (IU/mL)'}, {'measure': 'Severity of Torque Teno virus', 'timeFrame': 'Up to 1 year', 'description': 'Severity of Torque Teno virus measured by Torque Teno virus (TTV) (BAU/ml)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants attending the Miami Transplant Institute.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients over 18 years of age\n2. Lung transplant candidates with positive CMV IgG\n3. Anticipated to receive a lung transplant (both double lung and single lung)\n\nExclusion Criteria:\n\n1. Negative CMV IgG prior transplant\n2. Pregnant or breastfeeding women\n3. HIV infected patients\n4. Combined organ (e.g., lung-heart, lung-kidney) transplant candidates'}, 'identificationModule': {'nctId': 'NCT06494033', 'briefTitle': 'Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients: a Single Center Prospective Study', 'orgStudyIdInfo': {'id': '20230432'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prophylaxis guided by Cytomegalovirus-specific T cell Immunity', 'description': 'The immunological response of participants in this group will be followed for 1 year.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yoichiro Natori, MD', 'role': 'CONTACT', 'email': 'yxn138@med.miami.edu', 'phone': '3053556323'}, {'name': 'Lissett Moni', 'role': 'CONTACT', 'email': 'ltueros@med.miami.edu', 'phone': '3053555418'}, {'name': 'Yoichiro Natori, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Yoichiro Natori, MD', 'role': 'CONTACT', 'email': 'yxn138@med.miami.edu', 'phone': '3053556323'}, {'name': 'Lissett Moni', 'role': 'CONTACT', 'email': 'ltueros@med.miami.edu', 'phone': '3053555418'}], 'overallOfficials': [{'name': 'Yoichiro Natori, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurofins Viracor, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical', 'investigatorFullName': 'Yoichiro Natori', 'investigatorAffiliation': 'University of Miami'}}}}