Characterization of Diseases With Salivary Gland Involvement

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Dec 30, 2014

Keywords

ClinConnect Summary

This clinical trial is studying diseases that affect the salivary glands, which are important for producing saliva in the mouth and throat. Conditions like Sjogren's Syndrome and other salivary gland diseases can significantly impact a person's quality of life. The goal of the study is to gather information and samples from individuals who have these conditions, as well as from their relatives, to help researchers better understand these disorders and their genetics.

To participate, you need to be over 4 years old and either have a salivary gland disease, be suspected of having one, or be a relative of someone who does. Healthy volunteers aged 18 and older are also welcome to join. Participants can expect to undergo various tests during 2 to 3 visits, including medical history reviews, physical exams, and saliva collection. Some may also have minor procedures like a biopsy, where a small sample of tissue is taken from the salivary glands. It's important to know that certain health conditions may prevent you from taking part, so be sure to discuss any concerns with the study team.

Gender

ALL

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