Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT06513520
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in Geriatric Service
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A sample of blood (4mL EDTA tube and 4ml heparin tube)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mHLA DR expression', 'timeFrame': 'up to 72 Hour', 'description': 'Expression of mHLA DR assessed by flow cytometry and expressed as the number of antibodies bound per monocyte.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly patient', 'Immune system', 'mHLA DR', 'Immunosenescence', 'Multipathological subject'], 'conditions': ['Immune System']}, 'descriptionModule': {'briefSummary': 'The acceleration of population aging and the improved management of comorbidities lead to an increase in the number of multi-pathological elderly patients admitted to geriatric services. This is an extremely specific population in terms of immunology due to the presence of immunosenescence (physiological aging of the immune system) and the potential additional effect of multiple chronic pathologies (comorbidities) presented by these patients.\n\nThe specific effect of multiple chronic pathologies on the immune status of elderly patients is currently underexplored because most studies on immune system aging only include elderly patients who do not have comorbidities or treatments that could impact the immune system (e.g. SENIEUR protocol). Therefore, their results are not applicable to patients in geriatric services.\n\nThe decrease in monocyte expression of HLA-DR (mHLA-DR) has been studied as a marker of immune alteration in intensive care units in the context of sepsis, but also in chronic pathologies (e.g. cancer, diabetes, renal insufficiency). These chronic pathologies are frequently found in elderly subjects.\n\nThe objective of the study would therefore be to investigate the relative contribution of age (immunosenescence) and comorbidities to the alteration of the immune status of geriatric patients through the measurement of mHLA-DR.\n\nTo date, no study has explored mHLA-DR in a population of multi-pathological geriatric patients. Our work aims to generate initial data through a pilot study in hospitalized multi-pathological subjects over 75 years old in geriatric services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on polypathological patients aged over 75 hospitalised in a geriatric ward.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all patients:\n\n* Patients aged over 75 hospitalised in one of the geriatric units defined as the research sites;\n* Patient affiliated to a social security scheme;\n* Patients or relatives who have been informed and have no objections to the research.\n\nTo be eligible in the acute situation sub-population:\n\n\\- Patients presenting with an acute episode on admission or following a stay in the research sites; The acute episode is defined, for example, by an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised.\n\nTo be eligible in the stable situation sub-population:\n\n\\- A patient who has not had an acute episode for at least 7 days.\n\nExclusion Criteria:\n\nFor all patients:\n\n* Patients under legal protection: curatorship, guardianship, safeguard of justice ;\n* Patients under exclusive comfort care for whom it has been decided not to take a blood sample;\n* Patients undergoing long-term antibiotic treatment, i.e. with no defined stopping date;\n* An immunocompromised patient or a patient undergoing immunosuppressive treatment (for example: HIV infection, a patient awaiting solid organ transplantation, a patient undergoing haematopoietic stem cell transplantation, a patient undergoing chemotherapy for a solid tumour or haematological malignancy, a patient suffering from an auto-immune disease and being treated with immunotherapy and/or immunosuppressive therapy and/or biotherapy, an asplenic or hyposplenic patient, a patient undergoing experimental potentially immunosuppressive treatment, a patient undergoing Eculizumab treatment, a patient presenting a hereditary immune deficiency).\n\nFor patients in an acute clinical situation:\n\n\\- Patient previously included in the same sub-population.'}, 'identificationModule': {'nctId': 'NCT06513520', 'acronym': 'SENIOR HLA DR', 'briefTitle': 'Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in Geriatric Service', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in the Multi-pathological Elderly Subject in Geriatric Service', 'orgStudyIdInfo': {'id': '69HCL24_0650'}, 'secondaryIdInfos': [{'id': 'ID RCB', 'type': 'OTHER', 'domain': '2024-A01573-44'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients in acute medical situation', 'description': 'Patients over 75 with polypathology hospitalised in geriatric wards, in acute situation: for example, patients presenting with an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised.', 'interventionNames': ['Biological: Blood sampling']}, {'label': 'Patients in stable medical situation', 'description': 'Patients over 75 with polypathology hospitalised in geriatric wards, in a stable situation: these are patients who have not had an episode of decompensation or infection for at least 7 days.', 'interventionNames': ['Biological: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Additional blood tube collection during routine blood sampling.', 'armGroupLabels': ['Patients in acute medical situation', 'Patients in stable medical situation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69300', 'city': 'Caluire-et-Cuire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain GAUJARD', 'role': 'CONTACT'}], 'facility': 'Dugoujon Hospital', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain GAUJARD, MD', 'role': 'CONTACT'}], 'facility': 'Croix Rousse hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Sylvain GAUJARD, MD', 'role': 'CONTACT', 'email': 'sylvain.gaujard@chu-lyon.fr', 'phone': '+33 4 26 73 26 81'}, {'name': 'Léa VIEILLEDENT', 'role': 'CONTACT', 'email': 'lea.vieilledent@chu-lyon.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}