Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-01 @ 11:07 AM
Study NCT ID:
NCT04772092
Status:
WITHDRAWN
Last Update Posted:
2022-09-08
First Post:
2021-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Departure from the department of the principal investigator', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of immune cells in peripheral blood', 'timeFrame': 'At inclusion', 'description': 'technique used: flow cytometry'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geriatrics Immunosenescence']}, 'descriptionModule': {'briefSummary': "An individual's immune profile changes with age, and can sometimes be involved in the development of certain diseases such as infections or cancers, in a process called immunosenescence. Some data tend to show that there is a link between this immune profile and geriatric fragility (autonomy, difficulties with walking, memory, undernutrition, co-morbidities, depression). The aim of this study is to describe this profile, or immune phenotype, and to see if there is a link with the different aspects of geriatric assessment in patients without cancer or infection. In addition, these data will serve as a basis for comparison with the same analyses performed on breast cancer patients at the Centre Georges François Leclerc."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A person at least 70 years of age admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who has not opposed to inclusion in the study\n* Male or female aged 70 and over admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.\n\nExclusion Criteria:\n\n* Person not affiliated to national health insurance system\n* Person subject to a measure of legal safeguard (curatorship, etc)\n* Person with an acute infection\n* Person with suspected cancer or active cancer\n* Long-term immunosuppressive or corticosteroid therapy\n* HIV and/or HBV and/or HCV positive serology'}, 'identificationModule': {'nctId': 'NCT04772092', 'acronym': 'PHENOGERIA', 'briefTitle': 'Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older', 'orgStudyIdInfo': {'id': 'BARBEN 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Seniors', 'description': '70 years of age and over, inpatients or outpatients', 'interventionNames': ['Biological: Blood samples', 'Other: Data collection']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': 'during the routine blood test, collection of additional blood samples:\n\n* 1 x 5 mL heparinized tube for plasma collection and storage\n* 1 heparinized 5 mL tube for immunophenotyping\n* 4 x 10 mL EDTA tubes for white blood cell (WBC) collection and cryopreservation', 'armGroupLabels': ['Seniors']}, {'name': 'Data collection', 'type': 'OTHER', 'description': '* clinical examination data\n* test results to measure the degree of geriatric fatigability\n* Frailty screening questionnaire for neoplasia patients (G8 score)', 'armGroupLabels': ['Seniors']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}