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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065297
• Other study ID #: AUDIA-SAMSON HORTON TH17
• Status: Completed
• Start date: July 28, 2009

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• 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. 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

Related Conditions & MeSH terms

• Communicable Diseases
• Giant Cell Arteritis
• Hemopathy
• Horton's Disease
• Infection
• Infectious Disease
• Neoplasia
• Polymyalgia Rheumatica
• Solid Tumor

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