Characterization of Diseases With Salivary Gland Involvement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-100
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
About this trial
Background:
\- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics.
Objectives:
\- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives.
Eligibility:
* People more than 4 years old who have or are suspected to have a disease involving salivary glands. * Their relatives more than 4 years old. * Healthy volunteers 18 years or older.
Design:
* Participants may be screened with: * Medical history * Physical exam * Blood and urine tests * General oral and dental history and exam * Saliva collection * Eye exam and test for dry eyes * Health questionnaires (adults) * Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed. * Participants will have 2-3 visits. These may include: * Repeats of some screening tests * Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand. * Adults may have other biopsies * A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct. * Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup * Scrapings collected from teeth, tongue, and cheeks
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,150 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov