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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02065297
Other study ID # AUDIA-SAMSON HORTON TH17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 28, 2009

Study information

Verified date May 2019
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date
Est. primary completion date January 7, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

Other:
1 blood sample

2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)


Locations

Country Name City State
France CHU de BESANCON Besancon
France CHU de DIJON Dijon
France CH de METZ Metz

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum Up to 6 months
Primary Quantification of LTh17 by flow cytometry Up to 6 months
Primary Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA Up to 6 months
Primary Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations Up to 6 months
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