Salivary biomarkers for primary Sjögren's syndrome detection. A multi-center study. (Biomarker development study) - Salivary biomarkers for primary Sjögren's syndrome

niversitair Medisch Centrum Groningen0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Subjects greater than or equal to age 18 years of age.
•Subjects must have sicca symptoms, i.e. subjective dry mouth (xerostomia) and dry eyes (keratoconjunctivitis sicca, xeropthalmia) to be enrolled.
•Subjects willing to fill out questionnaire (approximately 10 min).
•Subjects should be willing to donate saliva.
•Subjects should be willing to have a labial biopsy in addition to a parotid biopsy.
•Subjects should be willing and able to give approximately 8 ml of blood.
•(for details see pages 15-16 of the protocol)

•Previous radiation to the head and neck (with exception of radioactive iodine for thyoid ablation therapy).
•Confirmed hepatitis C virus infection, which may cause SS-like signs and symptoms.
•Known HIV infection, which can cause salivary gland infiltrates and enlargements similar to SS.
•Sarcoidosis, which may cause SS-like signs and symptoms.
•Graft-versus-host disease, which may cause SS-like signs and symptoms.
•Oral cancer or history of oral cancer.
•Pregnancy based on self-report.
•Previously diagnosed with pSS or sSS using AECG criteria or SS using ACR criteria.
•Previously confirmed diagnosis of autoimmune disease known to be associated with Secondary Sjögren*s syndrome (sSS) (rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)), CREST (Calcinosis, Raynaud's syndrome, Esophageal dysmotility, Sclerodactyly, Telangiectasia), Scleroderma, Mixed connective tissue disease, Polymyositis.

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