Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-30 @ 6:24 PM
Study NCT ID:
NCT01524835
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Live Lung Donor Cross-sectional Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-01-31', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spirometric lung function', 'timeFrame': 'Measured at time of scheduled spirometry testing'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Throughout study'}, {'measure': 'Morbidity', 'timeFrame': 'Throughout study'}, {'measure': 'Psychosocial status, including anxiety and depression symptoms', 'timeFrame': 'Throughout study'}, {'measure': 'Satisfaction with live lung donation', 'timeFrame': 'Throughout study'}, {'measure': 'Decision-making associated with live lung donation', 'timeFrame': 'Throughout study'}, {'measure': 'Representativeness of participating live lung donor study sample', 'timeFrame': 'Throughout study'}, {'measure': 'Predictors of donor outcome and/or status', 'timeFrame': 'Throughout study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tissue Donors', 'Lung', 'Transplants', 'Transplantation'], 'conditions': ['Lung Transplantation']}, 'referencesModule': {'availIpds': [{'id': 'SDY294', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY294', 'type': 'Individual Participant Data Set', 'comment': 'ImmPort study identifier is SDY294'}, {'id': 'SDY294', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY294', 'type': 'Study Protocol', 'comment': 'ImmPort study identifier is SDY294. The study protocol is available in the Design tab section.'}, {'id': 'SDY294', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY294', 'type': 'Study summary, -design, -demographics, -study files', 'comment': 'ImmPort study identifier is SDY294'}], 'references': [{'pmid': '25039865', 'type': 'RESULT', 'citation': 'Yusen RD, Hong BA, Messersmith EE, Gillespie BW, Lopez BM, Brown KL, Odim J, Merion RM, Barr ML; RELIVE Study Group. Morbidity and mortality of live lung donation: results from the RELIVE study. Am J Transplant. 2014 Aug;14(8):1846-52. doi: 10.1111/ajt.12771.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID) website'}, {'url': 'https://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation (DAIT) website'}]}, 'descriptionModule': {'briefSummary': 'This study will gather information on the long-term effects of donating a lung lobe on living donors.', 'detailedDescription': "Over time, the number of patients on the lung transplant waiting list and the number of lung transplants performed have greatly increased. Unfortunately, the number of patients on the waiting list has outpaced the transplant rate, resulting in a significant number of deaths for patients on the waiting list.\n\nLive lung donation has the potential to decrease wait time for lung transplants and the rate of death for those awaiting transplants. However, since live lung donation typically utilizes one lobe of lung from each of two donors, transplantation puts two donors at risk for adverse events. Although live lung donation began in the early 1990s, there is still a great lack of published and comprehensive, long-term studies, leaving the outcome of live lung donation unclear. This study will assess post-donation outcomes in live lung donors. Specifically, investigators will determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. Information obtained from this study will allow potential future live lung donors and the interested public to become better informed, and may also assist potential donors in their decision-making process regarding the procedure. Furthermore, positive study results could potentially reassure previous live organ donors about uncertainties concerning their future health.\n\nThere will be 369 participants recruited for this study based on live lung donations, which occurred from 1993 through 2006. Study coordinators will contact eligible participants inviting participants to the study and answering any questions. Participants will have the option to partially or completely refuse participation. Each consenting donor will complete a series of questionnaires via phone and mail. The questions address issues related to the donor's quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. The questionnaires will take about one hour to complete. The coordinator will offer assistance regarding questionnaire completion and return. At the end of the study, a final brief status update will be obtained via phone interview.\n\nIn addition to questionnaires, participants will also be asked to participate in spirometry testing. For consenting participants, spirometry testing will be scheduled at either the two study sites or an approved Pulmonary Function Laboratory. During the test, the participant will breathe in and out of a plastic tube while a machine measures the amount and flow of air the donor breathes in and out. If deemed appropriate, the participant will do this test again a few minutes after being given albuterol, a drug which aims to optimize lung function. Spirometry testing will last about an hour."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Live lung donors who participated in transplantation during 1993 through 2006', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Donated a lung at University of Southern California or Washington University between January 1, 1993 and December 31, 2006\n\nExclusion Criteria:\n\n* For questionnaire testing: inability to comprehend and complete questionnaires (with assistance)\n* For spirometry: self-reported pregnancy, inability to reproducibly perform, and contraindications\n* For post-bronchodilator spirometry: allergy to albuterol'}, 'identificationModule': {'nctId': 'NCT01524835', 'briefTitle': 'Live Lung Donor Cross-sectional Cohort Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Live Lung Donor Cross-sectional Cohort Study', 'orgStudyIdInfo': {'id': 'DAIT RELIVE-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Live lung donors', 'description': 'Live lung donors who participated in donation from 1993 through 2006'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Mark Barr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Roger Yusen, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}