An observational study in Healthy Volunteer, Sjogren's Syndrome and Salivary Gland Disease, sponsored by National Institute of Dental and Craniofacial Research (NIDCR). Recruiting at 1 site in United States. Open to participants aged 4 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by National Institute of Dental and Craniofacial Research (NIDCR) · Observational
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:
Design:
This protocol is intended to allow disease-specific investigations in subjects with presentations of diseases with salivary gland involvement and will enable the collection of data, biological fluids and tissue samples from those subjects, their family members and normal controls, in order to assist our studies of understanding salivary gland disease pathophysiology. The exocrine salivary glands, by secreting saliva, play a critical role in the homeostasis of the oral cavity, which is the initial part of the gastrointestinal track. Several diseases including Parkinson s and systemic amyloidosis can be diagnosed through biopsies of easily accessible salivary glands. Moreover, several drugs and systemic diseases cause salivary gland hypofunction through unknown mechanisms.
We may evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell.
This protocol will provide us with the opportunity to learn from a variety of pathologies that involve directly or indirectly the salivary glands, expand our knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Information obtained through this protocol may lead to potential innovative therapeutic studies. In addition to its role in investigating individuals who are of interest to the Sjogren s syndrome (SS) and Salivary Gland Dysfunction Unit of the MPTB of NIDCR, this protocol can provide a possible avenue for enrolling subjects from other NIH programs or other NIH protocols that exhibit signs or symptoms associated with the salivary glands dysfunction.
Design:
This is a single-site, observational, natural history, definition of phenotype, genotype/phenotype correlation; prospective linkage/gene identification study. This study has three groups:
Group 1: Well-defined SS subject patients with matched adult healthy volunteers
Group 2: SS/other pathology-adults/minors patient subjects and affected and unaffected family members
Group 3: Subjects of interest with any cause for salivary gland dysfunction (adults and minors)
Outcome Measures:
Primary Endpoint:
This is primarily a hypothesis generating, descriptive study. 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.
Secondary Endpoints:
Mechanistic genetic and inflammatory endpoints will be studied to gain insight into the molecular mechanism of Sjogren's syndrome and other diseases related to salivary gland pathologies to generate hypotheses for future research. The mechanistic outcome measures may include, but will not be limited to, functional studies of epithelial and immune cells, various histologic measures and biomarker studies and generation of iPSC for future therapies. Summary statistics employed may include means, geometric means, minimum and maximum values, standard deviations, 90% confidence limits, medians, and frequencies as appropriate for the measure. Genomic and genetic studies will allow the exploration of genetic alterations that might cause or influence the studied salivary gland pathologies.
Exploratory Endpoints:
As above
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's planned enrollment of 1,150 is above the median of 139 across 100 observational studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →National Institute of Dental and Craniofacial Research (NIDCR) is the lead sponsor of 94 studies on the registry; 9 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with known or suspected Sjogren's syndrome and their family members (affected and unaffected) are potentially eligible participants. Subjects with other causes of salivary gland dysfunction (including hepatitis C) may also be potentially eligible for participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Or,
- Persons 18 years or older with active hepatitis with or without sicca symptoms and patients undergoing immunotherapy with an 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:
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.
Additional exclusion criteria for Healthy Volunteers (HV):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy Volunteers matched with Sjogren's Syndrome patients
Family Members, affected and unaffected
any other cause salivary gland dysfunction
hypothesis generating
hypothesis generating
Time frame: hypothesis generating
Plan to share: Yes — This is an observational study that began enrolling in 2015. De-identified data will be made public consistent with NIH policies.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: The time frame is at the time of publication or within a year of study completion.
Access criteria: The information will be shared publicly. No restrictions.
Started Apr 2015 (actual). Primary completion is estimated for Apr 2032, 203 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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