Frequently Asked Questions

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

What is the International Sjögren's Syndrome Biorepository and Data Registry?

The International Sjögren's Syndrome Biorepository and Data 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 came 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). Their collective efforts created the International Sjögren's Syndrome Biorepository and Data Registry.

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

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

Note: Participant enrollment is closed.

What were the criteria for participation?

Participants met 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 have been:

• At least 21 years of age at the time of enrollment
• Able to sign a research consent form

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

What did participation involve?

• An initial visit and a follow-up visit 2 years after the initial visit (follow-up visit only for participants with objective findings of Sjögren's syndrome):
• Interview and questionnaires
• Oral, ocular and brief rheumatologic examination
• Blood sample
• Labial salivary gland biopsy (if specimen is available from previously performed biopsy within the last three years, may fulfill the requirement for labial salivary gland biopsy at the initial visit.)
• Optional: one-time donation of blood or saliva from two immediate family members and a friend (control)