Construction of a biobank with peripheral blood and skin biopsies from patients with SSc, to evaluate (new) antigens and/or (new) antibodies and/or RNA expression profiles and to correlate these findings with clinical parameters (i.e. disease…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To construct a biobank with peripheral blood and material from skin biopsies
from patients with SSc to evaluate (new) antigens and/or (new) antibodies and
to compare these between subsets of SSc, and to correlate these findings to
disease characteristics like subsets of SSc (limited or diffuse cutaneous SSc,
limited SSc), disease duration, presence and extend of organ involvement (skin,
lung, heart, renal, gastrointestinal involvement). Studyparameters/ endpoints
will be determined depending hypotheses of experiments.
Secondary outcome
Secundary studyparameters/ endpoints will be determined depending hypotheses of
experiments.
Background summary
Systemic sclerosis (SSc) is a potentially devastating and progressive disease
with high mortality and morbidity. Its pathogenesis is still not completely
understood. A better understanding of the pathogenesis of SSc and the
formulation of valid and testable hypotheses might provide foundations for the
development of effective therapeutic agents. The construction of a biobank of
peripheral blood and skin biopsies from a large cohort of SSc patients provides
material for testing such hypotheses.
Study objective
Construction of a biobank with peripheral blood and skin biopsies from patients
with SSc, to evaluate (new) antigens and/or (new) antibodies and/or RNA
expression profiles and to correlate these findings with clinical parameters
(i.e. disease duration, type of SSc) and skin/ organ involvement (lung, heart,
renal).
Study design
Observational (nested case-control and cohort)
Study burden and risks
The risk and burden to the subject will be in proportion to the potential value
of the research, as patients with SSc continue to have a poor prognosis without
the perspective of being cured. Research for better delineation of the
pathogenesis of the disease may lead to the development of potential avenues,
such as cytokine-receptor decoys, that could be explored as therapeutic targets
for this disease.
Specified risk and burden: Number of extra institutional visits: none. Number
of blood samples: SSc patients: 1 per year (8 tubes (@ 30 ml) per occasion).
Skin biopsies: SSc patients with diagnosis < 4 years: baseline, 1, 2, 4 years
after diagnose with maximum of 10 biopsies. SSc patients with diagnosis > 4
years and iPAH patients: 1x 3 biopsies. Risks associated with investigation: in
rare cases (< 1%), delayed wound healing in SSc affected skin after biopsy.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Written informed consent
Exclusion criteria
None
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 | NL15478.029.06 |