Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02158208
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2014-03-05
Brief Title:
Study of the T CD8 Immune Response in Hortons Disease
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Study of the T CD8 Immune Response in Hortons Disease
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Horton CD8
Brief Summary:
The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Hortons disease
At the inclusion visit patients will have as is the case in the usual strategy
A complete clinical examination carried out by the doctor in charge of the patient
ESR and CRP and fibrinogen assay
A full blood count for leukocytes and lymphocytes
A biopsy of the temporal artery TAB to screen for signs of vascularitis suggesting Hortons disease The clinician in charge of the patient will decide if a second biopsy is necessary The biopsy will be sent to and analysed at Anatomy and Pathological cytology service Immunohistochemical analyses will be done if the TAB is positive
In addition to the standard clinical examination and complementary examinations relative to the patients pathology the following will be done
Lymphocyte immunophenotyping for the quantity of T CD4 cluster of differentiation 4 and CD8 lymphocytes B lymphocytes and natural killer lymphocytes This will make it possible to calculate the absolute value for different T lymphocyte populations
A blood sample drawn into a dry 5 mL tube large yellow to isolate the serum which will be stored at -80C for future assays for cytokines and other biomarkers of interest for Hortons disease
16 blood samples drawn into 6 mL heparinized tubes large green These will be used immediately for cytometric and functional analyses
At the inclusion visit patients will have as is the case in the usual strategy
A complete clinical examination carried out by the doctor in charge of the patient
ESR and CRP and fibrinogen assay
A full blood count for leukocytes and lymphocytes
A biopsy of the temporal artery TAB to screen for signs of vascularitis suggesting Hortons disease The clinician in charge of the patient will decide if a second biopsy is necessary The biopsy will be sent to and analysed at Anatomy and Pathological cytology service Immunohistochemical analyses will be done if the TAB is positive
In addition to the standard clinical examination and complementary examinations relative to the patients pathology the following will be done
Lymphocyte immunophenotyping for the quantity of T CD4 cluster of differentiation 4 and CD8 lymphocytes B lymphocytes and natural killer lymphocytes This will make it possible to calculate the absolute value for different T lymphocyte populations
A blood sample drawn into a dry 5 mL tube large yellow to isolate the serum which will be stored at -80C for future assays for cytokines and other biomarkers of interest for Hortons disease
16 blood samples drawn into 6 mL heparinized tubes large green These will be used immediately for cytometric and functional analyses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None