Understanding diseases that affect salivary glands

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate various diseases that involve salivary glands, such as Sjogren's Syndrome and other salivary gland disorders. It will collect data and biological samples from affected individuals, their relatives, and healthy volunteers to better understand the genetics and pathophysiology of these conditions. Participants will undergo a series of evaluations, including medical history assessments, physical exams, and saliva collection, to determine the causes and severity of salivary gland dysfunction. The findings may provide insights into the impact of these diseases on oral health and overall quality of life.

Why it matters

Who can join: the full rules

* 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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Margaret E Beach, P.A.-C — National Institute of Dental and Craniofacial Research (NIDCR)
• Study coordinator: Eileen M Pelayo
• Email: eileen.pelayo@nih.gov
• Phone: (301) 594-3097

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.