RecruitingNot Applicable

Characterization of Diseases With Salivary Gland Involvement

United States1,150 participantsStarted 2015-04-03

Plain-language summary

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

Who can participate

Age range

4 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is described as 'hypothesis generating' rather than testing a specific treatment, can you help me understand what I would actually gain personally by participating — or is this mainly contributing to future research?
2This trial is enrolling both healthy volunteers and people with Sjögren's syndrome or other salivary gland diseases — does my specific diagnosis affect what procedures or tests I'd be asked to go through, and are there any risks tied to salivary gland sampling I should know about?
3Since this study doesn't appear to be testing a therapy, would participating in any way affect or delay my access to standard treatments for my salivary gland condition?
4Given that Sjögren's syndrome can involve fatigue and other symptoms that affect daily life, what would the time commitment and visit schedule look like, and is that realistic for where I am in managing my condition right now?
5Are there other studies or clinical options focused on actual treatments for salivary gland disease or Sjögren's syndrome that might be worth considering alongside or instead of this observational study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

hypothesis generating

Timeframe: hypothesis generating

Trial details

NCT IDNCT02327884

SponsorNational Institute of Dental and Craniofacial Research (NIDCR)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2032-04-01

Contact for this trial

Eileen M Pelayo

(301) 594-3097 eileen.pelayo@nih.gov

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