Frequently asked Questions (FAQ)

Following are answers to basic questions about Sjögren's syndrome and the Sjögren's Syndrome Registry.

What is the International Sjögren's Syndrome Registry?

The International Sjögren's Syndrome Registry is funded by the National Institute of Dental and Craniofacial Research (NIDCR), the National Eye Institute (NEI), and the National Institutes of Health Office for Research on Women's Health, Bethesda, MD, USA.

A collaborative group of clinical and laboratory investigators from across the world work together to study individuals with Sjögren's syndrome and those who may have Sjögren's syndrome. This collaborative group of scientists is known as the Sjögren's International Collaborative Clinical Alliance (SICCA).

What are the goals of the International Sjögren's Syndrome Registry?

• To develop standardized diagnostic criteria for Sjögren's syndrome (SS).
• To oversee the collection, processing and storage of clinical data and biospecimens (tears, saliva, blood, minor salivary glands) from individuals with:
  
  
  • Primary SS
  • Secondary SS (with associated RA or SLE diagnosed by ACR criteria)
  • Symptoms of primary or secondary SS
  • Family members and unrelated controls of participants meeting the SICCA working standard for pSS or sSS
    
    
• To promote cutting-edge research in the area of Sjögren's syndrome with a focus on diagnosis, epidemiology, cause, prevention and treatment.

What are the criteria for participation?

To be eligible*, an individual should meet at least one of the following conditions:

• Complaint of dry eyes or dry mouth
• Previous diagnosis of primary or secondary (with RA or SLE as above) Sjögren's syndrome
• Abnormal serology (elevated ANA, RF, anti-SS-A, anti-SS-B)
• Bilateral parotid enlargement consistent with Sjögren's syndrome
• Multiple cervical/incisal dental caries in the absence of other risk factors

... and must also:

• Be at least 21 years of age
• Be able to sign a research consent form

*some previous treatments or conditions may make an individual ineligible to participate.

What does my participation involve?

• No treatment is provided as part of this clinical trial.
• You will be asked to do the following at an initial visit and at a follow-up visit (occurring 2 years after the initial visit if you are found to have objective findings of Sjögren's syndrome):
  
  
  • Complete an interview and questionnaires
  • Have an oral, ocular and brief rheumatologic examination
  • Provide a blood sample
  • Have a labial salivary gland biopsy. (An individual having one within the last three years may fulfill the requirement for labial salivary gland biopsy at the initial visit.)
    
    
• You may be asked to have two immediate family members and a friend provide a one-time donation of blood or saliva.

How do I participate?

The USA site expects to start enrolling individuals in the fall of 2004. If you are interested in participating or have additional questions, please e-mail sicca@dentistry.ucsf.edu. For the USA site, you may also call the Clinical Coordinator, Danielle Drury at (415) 476-0535.

How do I participate as a relative or friend of someone who is enrolled in the registry?

If you are referred to SICCA as a relative or friend of someone who is enrolled in the registry, you will be asked to contact us to provide a blood or saliva sample and complete brief questionnaires.