Setup method for detection of STAT3 phosphorylation in human blood derived from patients with various chronic inflammatory diseases.Test the effect of new compounds on this phosphorylation process.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Measurement of STAT3 phosphylation in different in vitro conditions in human
blood. Mainly by Facs analysis.
- Inhibition of the phosphorylation by various test compounds.
- Measurement of IL-23 in serum of patients.
Secondary outcome
- Expression of inflammatory mediators and surface markers in blood cells after
and during pSTAT3 phosphorylation.
Background summary
Psoriasis, Crohn's disease and SLE chronic inflammatory diseases with
relatively high incidence and which are are a high burden for the quality of
life. The current treatment methods are are not sufficient or show side
effects. The development and validation of nieuwe therapeutic strategies is
therefore warrented and should involve use of human material. The TNO life
sciences has gained extensive experience with the use of humane blood cells in
in vivo, ex vivo and in vitro pre-clinical testing. At this point, TNO wants to
use human blood to setup and study important signaling pathways in human blood
cells. In this particular study, we will focus on the fosforylation of a
transcription factor STAT3.
Additional, we will investigate whether new compounds (developed by a
pharmaceutical company) have an effect on this proces and therefore could
potentially be a new therapeutic strategy.
Scienticifc background information is attached in Appendix 2. Because this is a
pre-clinical study, patients will, for now, not benifit directly from this
research.
Study objective
Setup method for detection of STAT3 phosphorylation in human blood derived from
patients with various chronic inflammatory diseases.
Test the effect of new compounds on this phosphorylation process.
Study design
Pilot: Setup and validate the detection method
2-4 healthy controls/2-4 psoriasis patients/ 2-4 Crohns patients/ 2-4 SLE
patients will be recruited and 5 tubes (of 10cc) blood will be collected.
Blood will stimulated ex vivo using several protocols and the amount of
phosphorylated STAT3 will be determined by mainly use of FACS analysis.
Main study: test the effect of new compounds on the STAT 3 phosphorylation.
8-11 healthy controls/ 8-11 psoriasis patients/ 8-11 Crohns patients/8-11 SLE
patients will be recruited and 5 tubes of (10cc) blood will be collected.
Using the protocol optimized in the pilot study these blood samples will be
used to test the effect of 2-4 new compounds.
Study burden and risks
The burden and risk are considered to be very low as it entails only one
venopuncture.
Postbus 2215
2301 CE Leiden
NL
Postbus 2215
2301 CE Leiden
NL
Listed location countries
Age
Inclusion criteria
Psoriasis patients: Adults (m/f) with a mild form of psoriasis vulgaris (PASI score of maximal 6). Patients are allowed to use local corticosteroids or ointments to prevent dry skin
Crohn's: Adults (m/f) diagnosed with Crohn's disease. Patient must have experienced active disease in two years.
SLE: Adults (m/f) in remission or mild flare SLEDAI<5 .
Exclusion criteria
Psoriasis and Crohn's disease: patients have not received systemic treatment in last 2 months(methotrexate,cyclosporin A, corticosteroids, anti-TNF treatments) and no NSAIDS , iin last 6hours.
SLE: Patients have a SLEDAI <5. patients have not received systemic treatment in last 2 months(methotrexate,cyclosporin A, corticosteroids, anti-TNF treatments) and no NSAIDS , iin last 6hours.;Gender or age of the adults are not exclusion criteria (see Appendix 2).
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 | NL38405.028.11 |