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
This trial accepts healthy volunteersQualifiers
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 population
Subjects with known or suspected Sjogren's syndrome and their family members (affected and unaffected) are potentially eligible participants. Subjects with other causes of salivary gland dysfunction (including hepatitis C) may also be potentially eligible for participation.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,150 Participants
are grouped into 3 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Trial outcomes
Primary outcomes
1
hypothesis generating
hypothesis generating
Time frame
hypothesis generatingSponsors and contacts
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Source ClinicalTrials.gov