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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT02065297
Collaborator
(none)
143
3
47.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 1 blood sample
  • Other: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)

Study Design

Study Type:
Observational
Actual Enrollment :
143 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
Actual Study Start Date :
Jul 28, 2009
Actual Primary Completion Date :
Jan 7, 2016

Arms and Interventions

Arm Intervention/Treatment
Horton's disease

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

Infectious disease

Other: 1 blood sample

Neoplasia

Other: 1 blood sample

Control

Other: 1 blood sample

Outcome Measures

Primary Outcome Measures

  1. Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum [Up to 6 months]

  2. Quantification of LTh17 by flow cytometry [Up to 6 months]

  3. Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA [Up to 6 months]

  4. Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations [Up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de BESANCON Besancon France 25000
2 CHU de DIJON Dijon France 21079
3 CH de METZ Metz France 57000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02065297
Other Study ID Numbers:
  • AUDIA-SAMSON HORTON TH17
First Posted:
Feb 19, 2014
Last Update Posted:
May 6, 2019
Last Verified:
May 1, 2019

Study Results

No Results Posted as of May 6, 2019