Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04754503
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2021-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of commorbidity risk according Charlson score', 'timeFrame': 'At inclusion'}, {'measure': 'Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale', 'timeFrame': '12 Months'}, {'measure': "Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale", 'timeFrame': '12 months'}, {'measure': 'Assessment of quality of life according the SF-36 Health Status Questionnaire', 'timeFrame': '12 months'}, {'measure': 'Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'Assessment of survival and quality of life after liver transplantation according to the quality of life score', 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'Detecting depression in the elderly according the Geriatric Depression Scale (GDS)', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver transplant'], 'conditions': ['Patients Suitable for a Liver Transplant']}, 'descriptionModule': {'briefSummary': 'The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation', 'detailedDescription': "The expected benefits of this study are to identify the preoperative risk factors of mortality from liver transplant failure in patients aged 65 and over (90-day mortality and 1 and 3-year survival) will allow better selection. candidates for this age group. In the current context of organ shortage, this study should make it possible to reduce the number of risky transplants and thus improve the allocation of grafts.Inclusion of patients who meet the inclusion criteria will be carried out during their hospitalization in the surgical department of the hepato-bilary center.\n\nIncluded patients will receive a standardized geriatric assessment in addition to the usual assessment for a liver transplant.\n\nThe geriatric assessment will be carried out and conducted as follows: geriatric scores and quality of life questionnaires. Two geriatricians will perform the physical examination and blindly estimate each other's probability of survival at 90 days using a Likert scale.\n\nGeriatricians will be blinded to hepatic data (reasons for transplantation). The consultation as well as the completion of the questionnaire will be carried out during the pre-transplantation assessment.\n\nSurvival and quality of life will be assessed at 3 and 12 months post-transplantaion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 65 years of age who are candidates for a liver transplant at the participating center during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates for liver transplantation\n* Having expressed non-oppostion to his participation in study and documented in his medical file\n* With social coverage\n\nExclusion Criteria:\n\n* Emergency transplant patients\n* Patient already included in another study\n* Patient under guardianship or curatorship\n* Expressing his opposition to participate in the study'}, 'identificationModule': {'nctId': 'NCT04754503', 'acronym': 'LT 65+', 'briefTitle': 'Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over', 'orgStudyIdInfo': {'id': '2020-A03063-36'}}, 'contactsLocationsModule': {'locations': [{'zip': '94804', 'city': 'Villejuif', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle DURON, MD PhD', 'role': 'CONTACT', 'email': 'emmanuelle.duron@aphp.fr', 'phone': '+33(0)145593843'}], 'facility': 'Geriatric Department, Paul Brousse Hospital', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Isabelle Dufour', 'role': 'CONTACT', 'email': 'isabelle.dufour@gerondif.org', 'phone': '+33 (0)185781010'}, {'name': 'Prisca Lucas, PhD', 'role': 'CONTACT', 'email': 'prisca.lucas@gerondif.org', 'phone': '+33 (0)185781010'}], 'overallOfficials': [{'name': 'Duron Emmanuelle, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Geriatric Department, Paul Brousse Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}