To investigate the difference in number, phenotype and function of plasmacytoid dendritic cells and T cells in and between patients with SSc, LS and EF and between patients with these diseases and healthy controls / patients with psoriasis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Connective tissue disorders (excl congenital)
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number, phenotype and function of plasmacytoid dendritic cells and T cells in
the skin and blood of patients suffering from SSc, LS or EF and in healthy
controls / patients with psoriasis.
Secondary outcome
not applicable
Background summary
Systemic sclerosis (SSc) is a multifactorial autoimmune disorder eventually
causing fibrosis of the connective tissue such as skin and internal organs.
There is no effective treatment for SSc giving rise to a high unmet need.
Hence, further research to improve prognosis for these patients is highly
justified. Recent evidence from our group suggests an initial pathologic event
in the cells of the immune system in contrast to the current paradigm were
fibroblast are considered the primary cause. In fact, recent data shows an
increase of plasmacytoid dendritic cells (pDC) with an aberrant biology both in
the circulation and lesional skin of SSc patients. In addition, we discovered
new biomarkers, which are present in the early phase of the disease and predict
disease progression. However, how these pDCs and biomarkers orchestrate skin
fibrosis are largely unknown. More knowledge on this would not only provide
more insight into the pathogenic circuitry in SSc but also in other fibrosing
skin disorders for instance localized scleroderma (LS, morphea, linear
scleroderma) and eosinophilic fasciitis (EF). Most of the current research in
these fibrosing diseases is done with immune cells derived from the blood.
Investigating the immune cells present in the skin has the major advantage to
study the local processes in the affected areas.
Study objective
To investigate the difference in number, phenotype and function of plasmacytoid
dendritic cells and T cells in and between patients with SSc, LS and EF and
between patients with these diseases and healthy controls / patients with
psoriasis.
Study design
Observational, cross-sectional study.
Study burden and risks
There is no direct benefit for the participants in this study. A small scar
will develop at the site of the biopsy, this small scar will gradually fade in
color. Performing a biopsy entails a slight risk of hemorrhage and infection.
Bleeding of the skin can usually be stopped by simple compression of the wound
or by placing a small sponge in the wound. The risk of infection is generally
considered as relatively low. The risks of a venapuncture are generally
considered to be very low, it is possible that a haematoma develops at the site
of the puncture.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
-Age range: 18 - 75 years
-Diagnosed with systemic sclerosis, localized scleroderma, eosinophilic fasciitis or psoriasis.
Exclusion criteria
--Current use of coumarin derivatives
-Current use of cyclophosphamide
-IV corticosteroids in the last 14 days for inclusion
-Age <=17 years
-Patients with contra-indications for undergoing a skin biopsy (for example allergic to topical anesthetics)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43660.041.13 |