Clinical trial: Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome (NCT00001852)

Eligibility criteria:
-  INCLUSION CRITERIA:

        Male and female subjects.

        All subjects will have first participated in screening protocol 84-D-0056 to confirm their
        diagnosis and assess salivary function.

        Subjects must have dry mouth symptoms (xerostomia) and a diagnosis of primary or secondary
        SS, incomplete SS, or radiation-induced salivary gland dysfunction (as determined in
        protocol 84-D-0056).

        Diagnostic criteria for SS are the American-European Consensus Group Classification
        Criteria: For primary Sjogren s syndrome, any 4 of the 6 criteria, must include item IV
        (Histopathology) or VI (Auto-antibodies) or any 3 of the 4 objective criteria (III, IV, V,
        VI). For secondary Sjogren s syndrome, must have established connective tissue disease, one
        symptom (I or II) plus 2 of the 3 objective criteria (III, IV, VI).

        Ocular symptoms (at least one)

        Daily persistent dry eyes for greater than 3 months?

        Recurrent sensation of sand or gravel in the eyes?

        Use of tear substitutes greater than 3 x/day?

        Oral symptoms (at least one)

        Daily feeling of dry Mouth greater than 3 months

        Recurrent or persistently swollen salivary glands as an adult?

        Frequently drink liquids to aid in swallowing dry foods?

        Ocular signs (at least one)

        Schirmer s test, (without anesthesia) greater than or equal to 5mm/5 minutes

        Positive vital dye staining (van Bijsterveld greater than or equal to 4)

        Histopathology: Lip biopsy showing focal lymphocytic sialadenitis (focus score greater or
        equal to 1 per 4mm squared)

        Oral signs (at least one)

        Unstimulated whole salivary flow (greater or equal to 1.5 ml in 15 minutes)

        Abnormal parotid sialography

        Abnormal salivary scintigraphy

        Auto-antibodies (at least one)

        Anti-SSA (Ro) or Anti-SSB (La)

        EXCLUSION CRITERIA FOR DIAGNOSIS OF SS:

        Past head and neck radiation treatment

        Hepatitis C infection

        Acquired Immunodeficiency Syndrome (AIDS)

        Pre-existing lymphoma

        Sarcoidosis

        Graft versus host disease

        Current use of anticholinergic drugs

        EXCLUSION CRITERIA:

        Failure to complete evaluation procedures as specified in 84-D-0056.

        Diagnosis of drug-related xerostomia.

        Age less than 4 years.

        There are no exclusions based on gender, race, or ethnicity. Salivary gland dysfunction is
        uncommon in children and exceedingly rare in those less than 4 years old. Additionally, the
        evaluation method described in the protocol cannot be used in this age group.

        ULTRASOUND GUIDED CORE NEEDLE BIOPSY OF THE PAROTID GLAND

        Adult subjects already enrolled in this protocol and healthy volunteers will be eligible
        for this research procedure if they fulfill the criteria below and sign the parotid biopsy
        consent form. Healthy volunteers will be recruited only for the ultrasound guided core
        needle biospy of the parotid gland. They will sign the parotid biopsy consent form only.

        INCLUSION CRITERIA:

        Age 18 years or older.

        Ability to give informed consent.

        EXCLUSION CRITERIA:

        History of bleeding diathesis or the current use of anticoagulants.

        Any uncontrolled or severe chronic disease.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 4 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment