The International Sjögren's Registry
What is the Sjögren's Registry?
Why consider participating in the registry?
Who is eligible to participate and what is covered?
What criteria must be met for inclusion in the registry?
What tests and examinations will be performed?
Who do I contact to participate in the International Sjögren's Registry?
An initiative that will have a tremendous impact on the future of those who have Sjögren's syndrome has begun with the acceptance of patients during the Summer of 2004 in San Francisco.
"The International Sjögren's Syndrome Registry has the ultimate goal of promoting cutting-edge research in the area of Sjögren's syndrome with a focus on the diagnosis, epidemiology, causes, prevention and treatment," states Troy Daniels, DDS, MS - Co-Principal Investigator of the project with John Greenspan, DDS, PhD, at the University of California in San Francisco (UCSF). Nearly 12 million federal dollars over a five-year period will be provided for the Sjögren's International Collaborative Clinical Alliance (SICCA), the international organization of investigators focusing on the development of the registry. This level of support makes the registry the largest-ever research project on Sjögren's syndrome.
More than 6,000 people will be incorporated into the registry, including
both those with and those without Sjögren's syndrome. Information that is
gathered, along with samples of tissue, tears, saliva, and blood, will become
widely available to researchers for future studies. Results, but not patient
confidentiality, will be shared with investigators. "We will identify and follow a
cohort of Sjögren's patients and family and non-family controls," says
Greenspan, who adds that "the information obtained will be used for testing
hypotheses, defining the genetics, and hopefully will lead to clinical trials and
additional studies." Having such information accessible and in one location will
engender greater interest in Sjögren's, enable research to take place for those
who do not have the resources or ability to collect samples from so many
patients, and open the door for new ideas about Sjögren's and possible research
avenues. Greenspan concludes, "We may end up with something clearly defined, or
we may end up with a spectrum, an entity, that will lead us to rethink what we
know about Sjögren's."
The registry is funded by the National Institutes of Health, with a
leadership role taken by the National Institute of Dental and Craniofacial Research
(NIDCR) and joined by co-sponsors, the National Eye Institute (NEI) and
Office of Research on Women’s Health. The Sjögren's Syndrome Foundation played a
key role in initiating the registry and continues to provide input as the
registry is developed.
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Why consider participating in the registry?
The registry provides a learning opportunity rarely experienced for those who
care about Sjögren's syndrome. You can contribute to that effort and be a
critical part of an initiative that will provide fresh perspectives on this
disease and enable research to move forward so that better answers and treatments
can be found.
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Who is eligible to participate and what is covered?
You can reach the SICCA center at the University of California, San
Francisco, by e-mailing sicca@dentistry.ucsf.edu or by calling their Sjögren's Syndrome
Clinic at 415-476-2045. Once you have let the university know of your
interest, you will be asked to respond to a screening questionnaire. This initial
phase will take place by telephone or in person. If you pass this first stage,
you will be asked to participate in a baseline questionnaire with detailed
questions about your medical history. Successful candidates will then undergo
medical testing and examination.
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What criteria must be met for inclusion in the registry?
In order to be eligible for entry into the registry, individuals must be at least 21 years of age and have one or more of the following:
- Symptoms of dry eyes or dry mouth
- Elevated rheumatoid factor (RF), anti-nuclear antibody (ANA), anti-SS-A, or anti-SS-B
- Bilateral parotid enlargement consistent with Sjögren's syndrome
- Previous diagnosis of Sjögren's syndrome.
Exclusion criteria include any one of the following:
- Known diagnosis of another major autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or scleroderma
- Known diagnosis of hepatitis-C, HIV, sarcoidosis, amyloidosis, TB, graft-versus-host disease, cicatrizing conjunctivitis
- Past head or neck radiation treatment
- Physical or mental condition interfering with participation.
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What tests and examinations will be performed?
Once you have completed all questionnaires and investigators agree you are eligible for the next step, you will undergo the following examinations:
- Ocular examinations, including a Schirmer test, Lissamine green-Florescein staining, and tear break-up time
- Oral-salivary examinations, including unstimulated flow rate, parotid saliva collection, and labial salivary gland biopsy if you have not undergone this procedure in the previous two years
- Blood tests, including those for rheumatoid factor (RF), anti-nuclear antibody (ANA), anti-SS-A and anti-SS-B, quantitative immunoglobulins, complement, complete blood count, and anti-hepatitis-C, and blood samples for DNA and peripheral blood mononuclear cells.
If all tests are negative, you will not be recalled. If you have any positive findings, you will be followed even if you do not fulfill a working definition of Sjögren's. All of those followed and included in the registry will be re-examined two years after the initial testing.
Reimbursement for travel expenses to San Francisco is not available and treatment is not included. However, on-campus parking is provided and all testing in relation to the registry is free.
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Contact Information
You can reach the SICCA center at the University of California, San
Francisco, by e-mailing sicca@dentistry.ucsf.edu or by calling their Sjögren's Syndrome
Clinic at 415-476-2045. More information can also be found by visiting The Sjögren's Syndrome International Collaborative Clinical Alliance (SICCA) website.
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