Recruiting

Observational Study

Sponsor:

National Institute of Dental and Craniofacial Research (NIDCR)

Code:

NCT02327884

Conditions

Healthy Volunteer

Sjogren's Syndrome

Salivary Gland Disease

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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

Conditions

Healthy Volunteer

Sjogren's Syndrome

Salivary Gland Disease

Study ID

NCT02327884

Start date

Apr 3, 2015

Status verified date

May 6, 2026

Completion date

Apr 1, 2032

Anticipated

Primary completion date

Apr 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Accepted

  • 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 Design

Enrollment

1150 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Healthy Volunteers matched with Sjogren's Syndrome patients

Group 2

Family Members, affected and unaffected

Group 3

any other cause salivary gland dysfunction

Primary outcome measure

  • hypothesis generating [ Time Frame: hypothesis generating ]

Central Contacts and Locations

Central contacts

Eileen M Pelayo

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

Margaret E Beach, P.A.-C

(301) 451-3479margaret.beach@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Last update posted

Sep 1, 2026

Last verified

May 6, 2026

Keywords

  • Genetics
  • Dry Mouth
  • Sjogren's Syndrome
  • Gland dysfunction
  • Induced Pluripotent Stem (iPS) Cell Lines

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Dental and Craniofacial Research (NIDCR) on 2026-09-01.