Recruiting

Salivary Gland Disease Characterization and Data Collection

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to observe and collect data on salivary gland diseases to generate new hypotheses and insights for future research.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Arthritis+14

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

From 4 to 100 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2015
See protocol details

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Study ContactEileen M PelayoMore contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 3, 2015

Actual date on which the first participant was enrolled.

This study focuses on understanding diseases that affect the salivary glands, which are important for maintaining oral health by producing saliva. It aims to gather detailed information from patients with salivary gland issues, such as those with Sjogren's syndrome or other related conditions, and compare them with healthy individuals. This research is crucial because salivary gland dysfunction can lead to serious problems like increased tooth decay, oral pain, and difficulties with eating and speaking. By studying these conditions, researchers hope to better understand the causes and effects of salivary gland diseases, possibly leading to new treatments. Participants in this study include adults and minors with salivary gland issues, their family members, and healthy volunteers. They will provide samples of saliva, blood, and urine, and might undergo biopsies of their salivary glands. Researchers will analyze these samples to explore genetic and inflammatory aspects of the diseases, aiming to uncover underlying mechanisms. This observational study does not involve active treatment but focuses on gathering data to generate new ideas for future research. The findings could lead to innovative therapies and improve understanding of how these diseases affect the salivary glands.

Official TitleCharacterization of Diseases With Salivary Gland Involvement
NCT02327884
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Study ContactEileen M PelayoMore contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesEye DiseasesImmune System DiseasesJoint DiseasesLacrimal Apparatus DiseasesStomatognathic DiseasesMouth DiseasesMusculoskeletal DiseasesRheumatic DiseasesSalivary Gland DiseasesSjogren's SyndromeXerostomiaDry Eye SyndromesSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
Patients 18 years or older undergoing immunotherapy with an immune checkpoint inhibitor for treatment 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.).

Persons 18 years or older with active hepatitis with or without sicca symptoms.

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.

Show More Criteria

9 exclusion criteria prevent from participating
If unable to tolerate the study procedures, such as salivary gland biopsies, saliva collections, and/or oral exams, as determined by the Principal Investigator.

Sicca Symptoms

Anyone not able to give consent/assent or parental/guardian consent

NIH employees who report directly to the principal investigator

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center