Recruiting

Observational Study

Sponsor:

National Institute of Dental and Craniofacial Research (NIDCR)

Code:

NCT01425892

Conditions

Sjogren's Syndrome

Salivary Gland

Pathogenesis

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

-Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s Disease.

Objectives:

-To better understand how Sjogren s Disease begins and how it affects patients so that we can develop better ways to treat them.

Eligibility:

  • Participants must be 16 years of age or older.
  • They must have a diagnosis of Sjogren s Disease or have at least two symptoms of Sjogren s Disease.

Design:

  • People taking part in the study will come to the NIH Clinical Center for at least three visits.
  • During these visits, participants will have a medical history and physical exam. They will have oral and dental assessments, and saliva collection. Lab tests (blood and urine) and dry eye exams will be done. Participants will answer questionnaires and have salivary scintigraphy (adults only unless required for diagnosis).
  • Other optional tests may also be done. Participants may have to come in for additional visits if they have these optional tests or if their disease changes.
  • The only treatment provided as part of this study is for medical emergencies or complications that occur while you are at NIH for evaluation.

Conditions

Sjogren's Syndrome

Salivary Gland

Pathogenesis

Study ID

NCT01425892

Start date

Jan 18, 2012

Status verified date

Mar 17, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

1. Ability to sign informed consent form
2. Fulfilling one the definitions below:

1. Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)
2. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)
3. Incomplete SjD

i. at least 2 of the EA criteria with a common manifestation of SjD not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc) or

ii. 2 or more common manifestations of SjD which are not included in the EA criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions

EXCLUSION CRITERIA:

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1. Age <16 years
2. inability or unwillingness to comply with follow up requirements
3. Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)
4. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

incomplete sjogren's

patients who meet criteria as incomplete sjogren's

primary sjogren's

patients who meet criteria for classification for primary sjogren's

secondary sjogren's

patients who meet classification criteria for secondary sjogren's

Primary outcome measure

  • Clinical phenotyping of SjD patients and controls over time Collection of samples for concurrent and future laboratory studies related to the pathogenesis Identification of biomarker candidates in SjD [ Time Frame: patients are followed up to 10 years ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Last update posted

Aug 28, 2026

Last verified

Mar 17, 2026

Keywords

  • Sjogren's Syndrome
  • Salivary Gland
  • Pathogenesis
  • Natural History
  • Sj(SqrRoot)(Delta)gren s syndrome
  • Sjogrens Syndrome

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 2026-08-28.