Actively Recruiting

Age: 4Years - 100Years
All Genders
Healthy Volunteers
NCT02327884

Characterization of Diseases With Salivary Gland Involvement

Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-05-08

1150

Participants Needed

1

Research Sites

886 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Characterization of Diseases With Salivary Gland Involvement

Who Can Participate

Age: 4Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Persons older than 4 years of age, affected with or suspected to have a disease involving the salivary glands or who are relatives of such persons
  • Persons 18 years or older with active hepatitis, with or without sicca symptoms
  • Patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer, seen before and after therapy
  • Healthy persons age 18 or older who agree to have blood, urine, saliva, or tissue samples collected and studied
Not Eligible

You will not qualify if you...

  • Unable to give consent or lacking parental/guardian consent
  • NIH employees reporting directly to the principal investigator
  • Significant medical conditions or circumstances affecting ability to complete the study, such as concurrent chemotherapy or bleeding disorders
  • For immune checkpoint inhibitor patients: inability to tolerate study procedures like biopsies or saliva collection
  • For healthy volunteers: pregnancy
  • For healthy volunteers: sicca symptoms
  • For healthy volunteers: HIV, hepatitis B or C infection
  • For healthy volunteers: chronic medical illness except well-controlled hypertension or hyperlipidemia
  • For healthy volunteers: chronic use of medications except oral contraception, hormone replacement therapy, aspirin, antihypertensives, or antilipemics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

E

Eileen M Pelayo

CONTACT

M

Margaret E Beach, P.A.-C

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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