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Characterization of Diseases With Salivary Gland Involvement

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Procedures mentioned: Urine samples, Biopsies, Physical exams, Questionnaires, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Several diseases including Parkinson s and systemic amyloidosis can be diagnosed through biopsies of easily accessible salivary glands."
  • "This protocol will allow disease-specific investigations to enable the collection of data, tissue, saliva, and blood and urine samples on subjects, their family members and healthy controls, to assist in the understanding of disease pathophysiology."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at diseases of the salivary glands, which make saliva, and how genes may play a role. Researchers will collect health information and samples from people with these diseases, their relatives, and healthy adults.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People older than 4 who have, or may have, a disease that affects the glands that make saliva.
  • Relatives older than 4 of people with these diseases.
  • Adults 18 or older with active hepatitis (liver swelling), with or without dry eyes or dry mouth.
  • Adults 18 or older getting an immune checkpoint inhibitor for mouth cancer. This treatment helps the immune system fight cancer. Study visits happen before and after this treatment.
  • Healthy adults 18 or older who agree to give blood, urine, saliva, or tissue samples.

Who can't join

  • People who cannot give consent or agreement to join, or get consent from a parent or guardian.
  • NIH employees who report directly to the study leader.
  • People with a serious health problem or other issue that makes study visits or tests unsafe or hard to finish, such as chemotherapy or a bleeding disorder.
  • For people getting immune checkpoint inhibitors, mouth cancer alone does not rule them out. They cannot join if the study leader decides they cannot tolerate the study tests.
  • Healthy volunteers who are pregnant or have dry eyes or dry mouth.
  • Healthy volunteers with HIV or hepatitis B or C.
  • Healthy volunteers with a long-term illness, except well-controlled high blood pressure or high blood fats.
  • Healthy volunteers who take medicines long term, except birth control pills, hormone replacement therapy, aspirin, or medicines for high blood pressure or high blood fats.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MD