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Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)

NCT02065297 — Completed, 143 participants, Centre Hospitalier Universitaire Dijon

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RegistryNCT02065297
StatusCompleted
Study typeObservational
Enrollment143 (Actual)
SponsorCentre Hospitalier Universitaire Dijon (Other)
ConditionsHorton's Disease, Infectious Disease, Neoplasia, Solid Tumor, Hemopathy
Interventions1 blood sample, 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse) (Other)
Datesstart 2009-07-28, primary completion 2016-01-07, first posted 2014-02-19, last updated 2019-05-06
Locations3 sites in France

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Horton's diseaseOther: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)
Infectious diseaseOther: 1 blood sample
NeoplasiaOther: 1 blood sample
ControlOther: 1 blood sample
  • 1 blood sample (Other)
  • 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse) (Other)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 90 Years, accepts healthy volunteers

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

+Locations (3)

FacilityCityCountryStatus
CHU de BESANCONBesançonFrance
CHU de DIJONDijonFrance
CH de METZMetzFrance

My Notes