This research project aims to investigate the interaction between systemic immune cells and cells from the glandular tissue of patients with Sjögren's syndrome and sicca syndrome. We hope to obtain more insight in the cause and persistence of…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary immunological parameters:
1. activation of several types of immune cells before and after stimulation
with and without blockade of this stimulation (read-out measurements:
proliferation, activation markers, cytokine production and other inflammatory
mediators)
2. cytokine en biomarker profiles in serum and saliva.
These parameters will be compared between Sjögren patiënts, non-Sjögren sicca
patients, and healthy controls as outcome measurements.
Secondary outcome
These parameters will be compared between Sjögren patiënts and non-Sjögren
sicca patients as outcome measurements.
3. General disease parameters, which will be measured during their annual visit
to the outpatient clinic of the UMC Utrecht. (e.g. immunoglobulines, ESR,
leukocyte count).
4. unstimulated and stimulated salivary flow
5. unstimulated tear production
6. brief impression of general fatigue symptoms, and subjective dryness of
mouth and eyes with the use of questionnaires
Background summary
Patients with Sjögren's syndrome (pSS) suffer from several invalidating
symptoms, such as dryness, fatigue, and muscle- and joint complaints, caused by
a chronic activation of the immune system. An increased presence of different
types of immune cells is found within the salivary and lacrimal glands. There
is no cure for Sjögren's Syndrome, patients can only be treated
symptomatically. It is believed that a certain subset of T cells
(pro-inflammatory effector T cells) might play an important role in the
inflammation and glandular tissue destruction found in Sjögren's Syndrome.
Recently, it was discovered that these effector T cells can be identified
through a cell surface marker, the IL-7 receptor.
IL-7, a pro-inflammatory cytokine, that can potently activate these T cells, is
found to be elevated in the exocrine tissue of patients with Sjögren's
Syndrome. Eventually, inhibition of effector T cells through blockade of the
IL-7 receptor might be possible, which could lead to a more specific inhibition
of local inflammatory processes in the exocrine glands.
Study objective
This research project aims to investigate the interaction between systemic
immune cells and cells from the glandular tissue of patients with Sjögren's
syndrome and sicca syndrome. We hope to obtain more insight in the cause and
persistence of the inflammatory processes. This could lead to a better
understanding of the aetiology and extent of this disease and possibly a better
therapeutical stratification of patients with pSS. Our study will eventually
contribute to the search for new treatment regimes, particularly towards
specific immunomodulation of Sjögren's Syndrome.
Study design
*Cross-sectional study*. This research project does not include a 'clinical
trial'. Additionally, no intervention strategy will be applied. As part of
their regular healthcare, patients wil visit the reumatologist at the
outpatiënt clinic once, twice or several times a year.
In case they have several regular visits a year, it might be possible that we
will ask patients to donate their blood twice a year.
Study burden and risks
This study will not involve any direct advantages for the participants.
Participation to this research might lead to more insight in and a better
understanding of Sjögren's Syndrome. The major disadvantages:
Group 1: this group will undergo an extra venapunction, before the labial
salivary gland biopsy procedure. Furthermore, they will be asked to donate
saliva by spitting in a plastic cup and answering 2 short questionnaires. These
procedures will involve a slight burden for the patient and will cost 30
minutes of the patient's time.
Groep 2: similar as for group 1, with the exception of an extra venapunction.
Extra blood will be collected during the scheduled venapuncture as part of the
patient's annual visit to the outpatient clinic.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Group 1: Patients (>= 18 yr) with sicca complaints, with a suspicion of Sjögren's syndrome, and that will undergo lipbiopsy as a diagnostic tool
Group 2: Patients (>= 18 yr), who are diagnosed with Sjögren's syndrome, according to the revised American-European consensus group (Vitali, Bombardieri et al. 2002), with a lymphocytic focus score >=1 on minor salivary gland biopsy. Patients (>= 18 yr), who are diagnosed with non-Sjögren's sicca syndrome, with a lymphocytic focus score of 0 on minor salivary gland biopsy.
Healthy controls (>= 18 yr), recruited from the Minidonordienst (inhouse blood donating service) of the UMC Utrecht, who are free of the use of immunosuppressive drugs.
Exclusion criteria
Patients with any other causes of dryness will not be included in this study. Individuals that are not free of the use of immunosuppressive drugs at least 3 months prior to this study.
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 | NL25380.041.08 |