Clinical trial: Characterization of Diseases With Salivary Gland Involvement (NCT02327884)

Eligibility criteria:
-  INCLUSION CRITERIA:

          -  Persons older than 4 years of age, affected with or suspected of being affected with a
             disease/disorder involving the salivary glands or who is a relative of a person who is
             affected with these diseases/disorders.

        Or,

        - Persons 18 years or older with active hepatitis with or without sicca symptoms and
        patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer.

        Specific to patients undergoing immunotherapy with an immune checkpoint inhibitor for
        threatment of oral cancer, these patients will be seen before and after check point
        inhibitor therapy which will coincide with 4 weeks (+/-2 weeks) before and again
        immediately before (+/- 2 weeks) definitive oral cancer treatment initiation (e.g.,
        surgical resection, etc.).

        Or,

        - Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples
        collected and studied.

        EXCLUSION CRITERIA:

          -  Anyone not able to give consent/assent or parental/guardian consent

          -  NIH employees who report directly to the principal investigator

          -  Significant concurrent medical condition or other circumstances that may affect the
             participant s ability to tolerate or complete the study, such as concurrent
             chemotherapy or bleeding disorders.

               -  Specific only to the immune checkpoint inhibitor patients, oral cancer as a
                  serious concurrent medical condition, will not serve as an exclusion criteria.

               -  Moreover, these immune checkpoint inhibitor subjects, if unable to tolerate the
                  study procedures, such as salivary gland biopsies, saliva collections, and/or
                  oral exams, will be excluded as determined by the Principal Investigator.

          -  Additional exclusion criteria for Healthy Volunteers (HV):

               -  Pregnancy

               -  Sicca Symptoms

               -  HIV, hepatitis B or C infection

               -  Chronic medical illness, other than well-controlled hypertension or
                  hyperlipidemia

               -  Chronic use of medications, with the exception of oral contraception, hormone
                  replacement therapy, aspirin, antihypertensives and antilipemics
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