Study of the T CD8 Immune Response in Horton's Disease (Horton CD8)
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|ClinicalTrials.gov Identifier: NCT02158208|
Recruitment Status : Unknown
Verified May 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was: Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's 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 Horton's 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 -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
- 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.
|Condition or disease||Intervention/treatment|
|Horton's Disease||Other: Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment Other: 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment Other: Blood sample drawn into a 5 mL dry tube Other: 16 blood samples drawn into 6 mL heparinized tubes|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Study of the T CD8 Immune Response in Horton's Disease|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2015|
|Patients with HD||
Other: Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment
Other: 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment
Other: Blood sample drawn into a 5 mL dry tube
Other: 16 blood samples drawn into 6 mL heparinized tubes
- The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+) [ Time Frame: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158208
|Contact: Maxime SAMSON||220.127.116.11.32 ext +firstname.lastname@example.org|
|CHU de DIJON||Recruiting|
|Dijon, France, 21079|
|Contact: Maxime SAMSON 18.104.22.168.32 ext +33 email@example.com|