Clinical trial NCT02065297: Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
Official title: Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Horton's Disease
Infectious Disease
Neoplasia
Solid Tumor
Hemopathy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Horton' s disease Patients with an infectious disease Patients with neoplasia ( solid tumor or hemopathy ) Healthy controls

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum
timeFrame: Up to 6 months
measure: Quantification of LTh17 by flow cytometry
timeFrame: Up to 6 months
measure: Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA
timeFrame: Up to 6 months
measure: Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de BESANCON
city: Dijon
country: France
facility: CHU de DIJON
city: Metz
country: France
facility: CH de METZ
Study officials:
References: