Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06399302
Status:
RECRUITING
Last Update Posted:
2025-07-07
First Post:
2024-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The DCC will establish the centralized biorepository for the PROMISE-Lung Study at the University of Pennsylvania (Penn). Each specimen will be labeled with the study, sample ID, time-point, specimen type, and a unique barcode ID. Following local site processing, specimens will be locally stored at -80ᵒC at the participating site. Samples will then be batched and shipped on dry ice overnight to Penn at regular intervals. Shipments will be tracked to ensure arrival in a timely manner. Once received at Penn, all biological specimens for the cohort will be scanned into the laboratory information management system (LIMs) and stored at -80ᵒC. Biospecimens sent to Penn will be stored for future research studies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants enrolled and critical variable completeness', 'timeFrame': '3 years', 'description': 'To collect detailed clinical data, blood samples (including DNA), and PROs in 2,600 lung transplant candidates, donors, and recipients across the participating LTC centers to create a robust resource that will support a broad range of additional future clinical and translational research objectives'}, {'measure': 'Number of PROs collected per patient', 'timeFrame': '3 years', 'description': 'To collect clinical data and PROs that will specifically support future research studies to determine how variation in donor, surgical, or medical management practices across the participating LTC centers are associated with specific differences in relevant clinical outcomes such as PGD, AR, AMR, ALAD, post-transplant infections, PROs including health-related quality of life, or one-year survival.'}, {'measure': 'Number of specimens per participant collected', 'timeFrame': '3 years', 'description': 'To collect clinical data and biosamples that will specifically support future research studies to identify serum biomarkers that are associated with or predict the development of PGD, AR, AMR, ALAD, or CLAD.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant; Complications', 'Lung Transplant; Infection or Inflammation', 'Lung Transplant Rejection', 'Lung Transplant Failure']}, 'descriptionModule': {'briefSummary': 'This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.', 'detailedDescription': 'This is an observational, prospective, multicenter cohort study of 2,600 lung transplant donors and adult (18 years and older) lung transplant candidates and recipients that will collect longitudinal clinical data, and serial biological (blood) specimens and PROs to support a broad range of clinical and translational future research. Data and biospecimens will be rigorously collected and monitored to ensure high quality future studies that will address unmet needs and optimal management at each stage of the transplant journey from listing, to donor selection, to postoperative management. Subjects are recruited to the study either prior to undergoing lung transplant at the time of listing or within 30 days of having undergone a lung transplant at one of the enrolling centers.\n\nThe study design will generally follow the SOC practices at each center to minimize additional research related visits. Participants will follow the SOC transplant protocols at each site. Every attempt will be made by the site to collect study data and research specimens from participants at the time of SOC visits. Participation in this study will include scheduled data extraction or data transfers at specified time intervals, serial prospective blood collection (including plasma, serum), recipient DNA sample collection (with donor DNA sample collection optional), and PRO measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to understand and provide informed consent\n2. ≥ 18 years of age at the time of written informed consent\n3. Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days\n\n * Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/exclusion criteria.\n\nExclusion Criteria:\n\n1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol\n2. Pregnancy or plans to become pregnant\n3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study."}, 'identificationModule': {'nctId': 'NCT06399302', 'acronym': 'PROMISE', 'briefTitle': 'Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study', 'orgStudyIdInfo': {'id': 'Pro00114566'}, 'secondaryIdInfos': [{'id': 'U24HL163122', 'link': 'https://reporter.nih.gov/quickSearch/U24HL163122', 'type': 'NIH'}, {'id': 'PROMISE Study', 'type': 'OTHER', 'domain': 'LTC-DCC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung transplant donors and recipients', 'description': 'Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Perez', 'role': 'CONTACT', 'email': 'jsperez@mednet.ucla.edu', 'phone': '000-000-0000'}, {'name': 'Shahrzad Lari', 'role': 'CONTACT', 'email': 'shahrzadlari@mednet.ucla.edu'}, {'name': 'John Belperio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jon Singer, MD, MS', 'role': 'CONTACT', 'email': 'jon.singer@ucsf.edu', 'phone': '415-476-6030'}, {'name': 'Legna Betancourt', 'role': 'CONTACT', 'email': 'legna.betancourt@ucsf.edu', 'phone': '415-476-8073'}], 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Moni Lissett', 'role': 'CONTACT', 'email': 'ltueros@med.miami.edu', 'phone': '305-355-5418'}, {'name': 'Walter Brauchle', 'role': 'CONTACT', 'email': 'wab105@med.miami.edu'}, {'name': 'Juan Fernandez Castillo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joby Matthew', 'role': 'CONTACT', 'email': 'jmathe27@jhmi.edu', 'phone': '443-416-7573'}, {'name': 'Kelley Matt', 'role': 'CONTACT', 'email': 'mkelle51@jhmi.edu'}, {'name': 'Christian Merlo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nusrath Abdulla', 'role': 'CONTACT', 'email': 'nmovvalabdulla@bwh.harvard.edu', 'phone': '857-763-8868'}, {'name': 'Sam Wong', 'role': 'CONTACT', 'email': 'swong1@bwh.harvard.edu', 'phone': '000-000-0000'}, {'name': 'Hilary Goldberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brigham and Womens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jules Lin', 'role': 'CONTACT', 'email': 'juleslin@umich.edu', 'phone': '734-936-5738'}, {'name': 'Nicholas Demchuk', 'role': 'CONTACT', 'email': 'demchuni@med.umich.edu', 'phone': '734-936-3502'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adeline Beck', 'role': 'CONTACT', 'email': 'westm128@umn.edu', 'phone': '000-000-0000'}, {'name': 'Henry Madden', 'role': 'CONTACT', 'email': 'maddel123@umn.edu', 'phone': '612-725-5665'}, {'name': 'Stephen Huddleston', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shushaunna Bennett', 'role': 'CONTACT', 'email': 'shushaunna.bennett@nyulangone.org', 'phone': '646-630-2408'}, {'name': 'Cecilia Deterville', 'role': 'CONTACT', 'email': 'cecilia.deterville@nyulangone.org'}, {'name': 'Stephanie Chang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shreena Patel', 'role': 'CONTACT', 'email': 'sp3646@cumc.columbia.edu', 'phone': '973-722-6835'}, {'name': 'Leonor Suarez', 'role': 'CONTACT', 'email': 'ls955@cumc.columbia.edu', 'phone': '646-528-9006'}, {'name': 'Luke Benvenuto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurie Snyder, MD, MHS', 'role': 'CONTACT', 'email': 'laurie.snyder@duke.edu', 'phone': '919-684-2240'}, {'name': 'Erika Buckley', 'role': 'CONTACT', 'email': 'erika.buckley@duke.edu', 'phone': '919-660-7222'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Johnson', 'role': 'CONTACT', 'email': 'jessica.johnson@pennmedicine.upenn.edu', 'phone': '610-731-1661'}, {'name': 'Jason Christie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ritchie Koshy', 'role': 'CONTACT', 'email': 'koshyrg@upmc.edu', 'phone': '412-802-8624'}, {'name': 'Amanda Zeng', 'role': 'CONTACT', 'email': 'zengal@upmc.edu', 'phone': '412-383-1818'}, {'name': 'John McDyer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Smithson', 'role': 'CONTACT', 'email': 'lisa.smithson@vumc.org', 'phone': '615-875-8253'}, {'name': 'Tansy Gaines', 'role': 'CONTACT', 'email': 'tansy.v.gaines@vumc.org', 'phone': '256-348-1431'}, {'name': 'Lorraine Ware', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thao-chi Vo', 'role': 'CONTACT', 'email': 'thao-chi.vo@inova.org', 'phone': '703-776-8041'}, {'name': 'Edwinia Battle', 'role': 'CONTACT', 'email': 'edwinia.battle@inova.org', 'phone': '703-776-7691'}, {'name': 'Shambhu Aryal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chelsea Schmitz', 'role': 'CONTACT', 'email': 'cschmitz@uw.edu', 'phone': '916-247-5438'}, {'name': 'Michaela Blanchard', 'role': 'CONTACT', 'email': 'michejb@uw.edu', 'phone': '408-834-2141'}, {'name': 'Michael Mulligan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Devereaux', 'role': 'CONTACT', 'email': 'mdevereaux@medicine.wisc.edu', 'phone': '000-000-0000'}, {'name': 'Melanie Nelson', 'role': 'CONTACT', 'email': 'mmnelson@medicine.wsic.edu', 'phone': '000-000-0000'}, {'name': 'Erin Lowery', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sara Grzywnowicz', 'role': 'CONTACT', 'email': 'sara.grzywnowicz@uhn.ca', 'phone': '000-000-0000'}, {'name': 'Kseniya Krasyuk', 'role': 'CONTACT', 'email': 'kseniya.krasyuk@uhn.ca'}, {'name': 'Shaf Keshavjee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Allyn Damman', 'role': 'CONTACT', 'email': 'allyn.damman@duke.edu', 'phone': '919-259-4414'}, {'name': 'Carl Schuler, RN', 'role': 'CONTACT', 'email': 'carl.schuler@duke.edu', 'phone': '919-695-2721'}], 'overallOfficials': [{'name': 'Scott M Palmer, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University School of Medicine, Department of Medicine'}, {'name': 'Jason D Christie, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Megan L Neely, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University School of Medicine, Department of Biostatistics and Bioinformatics'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data from each cycle of an examination or follow-up component are prepared by the DCC and sent to the NHLBI Program Officer for distribution no later than 3 years after the completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized within the study for analysis for use in publication, whichever comes first.', 'ipdSharing': 'YES', 'description': "After the study is completed, information about the study, including study data, will be submitted to the NIH data repository. NHLBI's BioData Catalyst will be used for data, and BioLINCC will be used for biosample deposition after study completion.", 'accessCriteria': 'The overall governance of the protocol is under the guidance of the NHLBI and the steering committee, composed of members of the DCC and UO1 site representatives. Future studies using these sample will be governed by an ancillary committee of the steering committee.\n\nIn addition, further analysis using this data may occur via ancillary studies that are submitted separately for IRB review.\n\nhttps://biodatacatalyst.nhlbi.nih.gov/ https://biolincc.nhlbi.nih.gov/home/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}