Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT05546632
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity of anti-HLA-DR antibodies per cell', 'timeFrame': 'The day of inclusion', 'description': 'The quantity of anti-HLA-DR antibodies per single cell will be assessed in each tube (EDTA and Cyto Chex) using flowcytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive care unit', 'HLA-DR', 'blood sample', 'Cyto-chex tube', 'EDTA tube'], 'conditions': ['Critical Care']}, 'descriptionModule': {'briefSummary': 'The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.\n\nThe investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on patients hospitalized in the intensive care unit of the Edouard Herriot hospital in Lyon', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patient hospitalized in intensive care unit\n* Patient able to consent and having expressed his non-objection (in the case where the patient is aware) OR Patient whose trusted person has given his non-objection (in the case where the patient is not able to consent, example intubated patient)\n\nExclusion Criteria:\n\n* Pregnant women\n* Minors\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons subject to psychiatric care\n* Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)\n* Patient who doesn't understand French language"}, 'identificationModule': {'nctId': 'NCT05546632', 'acronym': 'CHEX-DR', 'briefTitle': 'Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry', 'orgStudyIdInfo': {'id': '69HCL22_0446'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients', 'description': 'Patients included in this study will have blood sampling using EDTA tube and nex generation Cyto-Chex BCT tubes in order to compare compare the expression of mHLA-DR with these two types of tubes', 'interventionNames': ['Diagnostic Test: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will have one blood sampling using one EDTA tube and one Cyto-Chex BCT tube, one after the other', 'armGroupLabels': ['Critically ill patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de reanimation chirurgicale', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Anne-Claire LUKASZEWICZ, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}