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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02065297
First received: February 13, 2014
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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 Intervention
Horton's Disease
Infectious Disease
Neoplasia
Solid Tumor
Hemopathy
Other: 1 blood sample
Other: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Quantification of LTh17 by flow cytometry [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065297

Contacts
Contact: Sylvain AUDIA 3.80.29.34.32 ext +33 sylvain.audia@chu-dijon.fr

Locations
France
CHU de BESANCON Recruiting
Besancon, France, 25000
Contact: Nadine MAGY-BERTRAND    3 81 66 89 15 ext +33      
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Sylvain AUDIA    3.80.29.34.32 ext +33    sylvain.audia@chu-dijon.fr   
CH de METZ Recruiting
Metz, France, 57000
Contact: François MAURIER    3 87 39 47 72 ext +33      
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02065297     History of Changes
Other Study ID Numbers: AUDIA-SAMSON HORTON TH17
Study First Received: February 13, 2014
Last Updated: February 13, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Polymyalgia Rheumatica
Giant Cell Arteritis
Neoplasms
Communicable Diseases
Infection
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014