NCT02327884

Characterization of Diseases With Salivary Gland Involvement

Recruiting now Last updated 1 April 2026

What this trial tests

trial in Healthy Volunteer in 1,150 participants. Currently enrolling.

Timeline

3 April 2015

Primary endpoint
1 April 2032

1 April 2032

Quick facts

Lead sponsor	National Institute of Dental and Craniofacial Research (NIDCR)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,150
Start date	3 April 2015
Primary completion	1 April 2032
Estimated completion	1 April 2032
Sites	1 location across United States

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →
• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →
• Salivary Gland Disease — all drugs for Salivary Gland Disease →

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Who can join

Adults 4 to 100, any sex, with Healthy Volunteer or Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. SARS-CoV-2 infection of the oral cavity and saliva.
   Huang N, Pérez P, Kato T, Mikami Y, et al · · 2021 · cited 596× · PMID 33767405 · DOI 10.1038/s41591-021-01296-8
2. T cell exosome-derived miR-142-3p impairs glandular cell function in Sjögren's syndrome.
   Cortes-Troncoso J, Jang SI, Perez P, Hidalgo J, et al · · 2020 · cited 62× · PMID 32376798 · DOI 10.1172/jci.insight.133497
3. LAMP3 induces apoptosis and autoantigen release in Sjögren's syndrome patients.
   Tanaka T, Warner BM, Odani T, Ji Y, et al · · 2020 · cited 43× · PMID 32939030 · DOI 10.1038/s41598-020-71669-5
4. TScan-II: A genome-scale platform for the de novo identification of CD4<sup>+</sup> T cell epitopes.
   Dezfulian MH, Dezfulian MH, Kula T, Pranzatelli T, et al · · 2023 · cited 41× · PMID 38016469 · DOI 10.1016/j.cell.2023.10.024
5. Inhibition of JAK-STAT pathway corrects salivary gland inflammation and interferon driven immune activation in Sjögren's disease.
   Gupta S, Yamada E, Nakamura H, Perez P, et al · · 2024 · cited 26× · PMID 38527764 · DOI 10.1136/ard-2023-224842
6. Lysosomal exocytosis of HSP70 stimulates monocytic BMP6 expression in Sjögren's syndrome.
   Mo YQ, Nakamura H, Tanaka T, Odani T, et al · · 2022 · cited 22× · PMID 35113815 · DOI 10.1172/jci152780
7. Sclerosing Sialadenitis Is Associated With Salivary Gland Hypofunction and a Unique Gene Expression Profile in Sjögren's Syndrome.
   Yin H, Pranzatelli TJF, French BN, Zhang N, et al · · 2021 · cited 16× · PMID 34400910 · DOI 10.3389/fimmu.2021.699722
8. Dysregulated long non-coding RNA in Sjögren's disease impacts both interferon and adaptive immune responses.
   Joachims ML, Khatri B, Li C, Tessneer KL, et al · · 2022 · cited 14× · PMID 36456101 · DOI 10.1136/rmdopen-2022-002672