Solid Tumor Clinical Trial
Official title:
Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
NCT number | NCT02065297 |
Other study ID # | AUDIA-SAMSON HORTON TH17 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 28, 2009 |
Verified date | May 2019 |
Source | Centre Hospitalier Universitaire Dijon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de BESANCON | Besancon | |
France | CHU de DIJON | Dijon | |
France | CH de METZ | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
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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