Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT04667806
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Related Quality of Life in Lung Transplantation in Strasbourg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': '12 month', 'description': 'Score obtained by a questionnaire : SF36'}, {'measure': 'Health related quality of life', 'timeFrame': '12 month', 'description': 'Score obtained by a questionnaire : St Georges'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health related quality of life', 'Lung transplantation', 'SF36', "St Georges's Respiratory"], 'conditions': ['Lung Transplantation']}, 'descriptionModule': {'briefSummary': "The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score).\n\nThe secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transplants survivors in Strasbourg hospital between 2008 et 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transplants survivors in Strasbourg hospital between 2008 et 2018\n* Patient able to answer a questionnaire in french\n\nExclusion Criteria:\n\n* Pregnancy\n* Vulnerability\n* Safeguard of justice, curatorship or tutorship\n* Emergency situation\n* Difficilty in understanding'}, 'identificationModule': {'nctId': 'NCT04667806', 'briefTitle': 'Health Related Quality of Life in Lung Transplantation in Strasbourg', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "Study of the Quality of Life in Surviving Lung Transplant Patients Between 2008 and 2018 by SF36 and St Georges's Questionnaires", 'orgStudyIdInfo': {'id': '7952'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': "Use questionnaires ( SF36 questionnaire (generic score) and St Georges's questionnaire (specific score))"}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Lina JAZERLI', 'role': 'CONTACT', 'email': 'lina.jazaerli@chru-strasbourg.fr', 'phone': '+33 3 69 55 16 22'}, {'name': 'Lina JAZERLI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olivier COLLANGE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul-Michel MERTES', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Lina JAZAERLI', 'role': 'CONTACT', 'email': 'lina.jazaerli@chru-strasbourg.fr', 'phone': '+ 33 3 69 55 16 22'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}