Study of the T CD8 Immune Response in Horton's Disease (NCT02158208) | Clinical Trial Compass
CompletedNot Applicable
Study of the T CD8 Immune Response in Horton's Disease
France30 participantsStarted 2013-07-25
Plain-language summary
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients
* Patients who have provided written informed consent
* Patients covered by national health insurance
* Age \> 50 years
* Patients with Horton's disease at the diagnosis before any treatment
Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated:
* age at the onset of the disease 50 years or above
* recent onset localised headache
* indurated temporal artery or decrease/absence of temporal pulse
* erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP\>20 mg/L)
* positive TAB showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells.
Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (CRP\<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be matched for age and sex.
* Age \> 50 years
* Patients covered by national health insurance
* who have provided written informed consent to take part
* Absence of inflammatory syndrome (CRP\<5 mg /L)
Exclusion Criteria:
* Any patient not meeting inclusion criteria
* Patient treated with corticoids or immunosuppressants in the month preceding inclusion
* Patients treated with chemotherapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)
Timeframe: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment