The participants in the SICCA cohort have been enrolled since 2004 at five collaborating academically-based research groups, located in Argentina, China, Denmark, Japan and the United States, and directed from the University of California, San Francisco (12 (link)) (Table 1 ). Subsequently, additional research groups joined the SICCA project: in 2007, from the United Kingdom and in 2009, from India and two additional sites in the United States.
To be eligible for the SICCA registry, participants must be at least 21 years of age and have at least one of the following: symptoms of dry eyes or dry mouth; a previous suspicion or diagnosis of SS; elevated serum antinuclear antibodies (ANA), positive rheumatoid factor (RF), or anti-SSA/B; bilateral parotid enlargement in a clinical setting of SS; a recent increase in dental caries; or have diagnoses of rheumatoid arthritis or systemic lupus erythematosus and any of the above. The rationale for these eligibility criteria is that only patients with such characteristics would be evaluated for SS or considered for enrollment in a clinical trial designed to evaluate a potential therapeutic agent for SS. Therefore our classification criteria target individuals with signs and symptoms that may be suggestive of SS, not the general population.
Participants are recruited through local or national SS patient support groups, healthcare providers, public media, and populations served by all nine SICCA research groups. Exclusion criteria include known diagnoses of: hepatitis C, HIV, sarcoidosis, amyloidosis, active tuberculosis, graft versus host disease, autoimmune connective tissue diseases other than rheumatoid arthritis or lupus; past head and neck radiation treatment; current treatment with daily eye drops for glaucoma; corneal surgery in the last 5 years to correct vision; cosmetic eyelid surgery in the last 5 years; or physical or mental condition interfering with successful participation in the study. Contact lens wearers are asked to discontinue wear for 7 days before the SICCA examination. We do not exclude participants taking prescription drugs that may affect salivary or lacrimal secretion, but record their use and all other medications currently taken.
To be eligible for the SICCA registry, participants must be at least 21 years of age and have at least one of the following: symptoms of dry eyes or dry mouth; a previous suspicion or diagnosis of SS; elevated serum antinuclear antibodies (ANA), positive rheumatoid factor (RF), or anti-SSA/B; bilateral parotid enlargement in a clinical setting of SS; a recent increase in dental caries; or have diagnoses of rheumatoid arthritis or systemic lupus erythematosus and any of the above. The rationale for these eligibility criteria is that only patients with such characteristics would be evaluated for SS or considered for enrollment in a clinical trial designed to evaluate a potential therapeutic agent for SS. Therefore our classification criteria target individuals with signs and symptoms that may be suggestive of SS, not the general population.
Participants are recruited through local or national SS patient support groups, healthcare providers, public media, and populations served by all nine SICCA research groups. Exclusion criteria include known diagnoses of: hepatitis C, HIV, sarcoidosis, amyloidosis, active tuberculosis, graft versus host disease, autoimmune connective tissue diseases other than rheumatoid arthritis or lupus; past head and neck radiation treatment; current treatment with daily eye drops for glaucoma; corneal surgery in the last 5 years to correct vision; cosmetic eyelid surgery in the last 5 years; or physical or mental condition interfering with successful participation in the study. Contact lens wearers are asked to discontinue wear for 7 days before the SICCA examination. We do not exclude participants taking prescription drugs that may affect salivary or lacrimal secretion, but record their use and all other medications currently taken.
