Wegener's Granulomatosis Clinical Trial
— DAP12WEGENEROfficial title:
Activating Receptors and DAP12 Protein in Wegener's Granulomatosis
Verified date | April 2015 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an assortment of activating NK cell receptors and their signaling partners, in particular DAP12. The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the missing link between the different cell components involved in WG (neutrophils, macrophages, CD4 T cells).
Status | Completed |
Enrollment | 138 |
Est. completion date | September 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Group 1: WG, with granulomatous lesions limited to upper airway or lungs and no evidence of generalized vasculitis ,± biopsy, ± anti-PR3 ANCA - Group 2: WG with granulomatous lesions plus vasculitis expression (renal, neurological, skin, gut or heart involvement), ± biopsy, ± anti-PR3 ANCA - Group 3: Necrotizing vasculitis with no granulomatous lesions, ± PAUCI immune glomerulonephritis, ± anti-MPO ANCA - Group 4: clinical presentation compatible with sarcoidosis, ± biopsy, ± ECA elevated ± tuberculin anergy Exclusion Criteria: - <18 years - Pregnancy or breastfeeding - Absence of signed informed consent - No affiliation to insurance |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Medecine Interne Hôpital Saint Louis | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | level of mRNA expression of DAP12 | Measure:level of mRNA expression of DAP12 by RT-PCR in CD4+T cells, macrophages and neutrophils | less than 24 hours | No |
Secondary | level of expression of DAP 12 downstream signalling proteins | Measure: level of expression of DAP 12 downstream signalling proteins in CD4+ T cells, macrophages and neutrophils | Less than 24 hours | No |
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