NCT Number: NCT02065297
Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease.
Participation consists in taking one or several blood samples depending on the group patients/controls.
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU de BESANCON, Besançon, France
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Age: 50 to 90 years
Patients with Horton' s disease :
- at the diagnosis, before any treatment
- or in remission
- or in relapse
Patients with an infectious disease :
- Bacteriologically or radiologically confirmed
- Presenting an inflammatory syndrome defined by :
- CRP ≥ 10 mg / L
- and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1
Patients with neoplasia ( solid tumour or hemopathy ) :
- At the diagnosis, before treatment by chemotherapy
- Presenting an inflammatory syndrome defined by:
- CRP ≥ 10 mg / L
- and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1
Controls :
These are healthy volunteers recruited among blood donators at Dijon CHU, voluntary hospital personnel ( nurses, doctors and secretaries ), patients at the EPHAD ( Champmaillot centre for geriatric patients ) and patients without infectious, inflammatory, or auto-immune disease ( CRP < 5mg / L ) or cancer recruited from the investigating departments of Dijon CHU. They will be matched for age and sex.
- Age: 18 - 90 years
- Patients with national health insurance cover
- who have provided written informed consent
- Absence of an inflammatory syndrome ( CRP < 5 mg / L )
Exclusion criteria
- Any patient who does not meet the inclusion criteria
Treatment and study plan
2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)
OtherPrimary outcomes
-
Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum
Time frame: Up to 6 months
-
Quantification of LTh17 by flow cytometry
Time frame: Up to 6 months
-
Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA
Time frame: Up to 6 months
-
Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations
Time frame: Up to 6 months
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire Dijon
Other
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2016
- First posted
- Feb 19, 2014
- Registry last updated
- May 6, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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