An observational study in Sjogren's Syndrome, Autoimmune Diseases and Dry Eyes, sponsored by University of Florida. Withdrawn at 1 site in United States. Open to participants aged 9 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by University of Florida · Observational
Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia, lack of concentration, memory loss and various psychiatric disorders. Like most autoimmune connective tissue diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than men, suggesting a role for sex hormones in disease susceptibility or progression. One common feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La autoantigens. The goal of this study is characterize the change in receptor gene repertoires of autoreactive B and T cells at different time points during the disease process and examine the correlation with various disease parameters.
Blood from patient and healthy controls will be collected once every 3-6 months. White blood cells from blood samples will be separated. Tests will be done to see which substances these cells make. Using sequencing techniques, the investigators will determine the genetic code of the receptors expressed on these cells. The investigators plan to test how these cells change over the period of at least 3 years at different visits. In addition, the investigators will check how these changes relate to patients' general medical history relevant to autoimmune disease, lab results and physical examinations and exams pertinent to the diagnosis of autoimmune disease, and psychosocial data.
381 studies on the registry are indexed under Sjogren's Syndrome; 106 are open to participants now.
Browse Sjogren's Syndrome studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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150 Sjogren's syndrome patients and 50 healthy controls.
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Inclusion Criteria for Sjogren's syndrome patients:
Inclusion Criteria for healthy controls:
-Subjects who does not have history of autoimmune diseases.
Exclusion Criteria:
Patients who are diagnosed with Sjogren's syndrome. Blood will be collected once every 3-6 months for up to 3 years.
Patients who are diagnosed with healthy control. Blood will be collected once every 6 months for up to 3 years.
Receptor gene rearrangement.
Gene arrangement of the receptors in patients will be assessed every 3 months for 3 years.
Time frame: Every 3 months for 3 years
Receptor gene rearrangement
Gene arrangement of the receptors in healthy controls will be assessed every 6 months for 3 years.
Time frame: Every 6 months for 3 years.
The record gives a start of Jul 2014, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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