The Pathogenesis and Natural History of Sjogren's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-100
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
About this trial
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....
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to sign informed consent form
Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)
Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)
Incomplete SjD
Disqualifiers
Age <16 years
inability or unwillingness to comply with follow up requirements
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)
NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.
Trial population
The population consists of patients who have completed our Sjogren's screening protocol (15-D-0051) and are deemed eligible to enroll in this pathogenesis protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: incomplete sjogren's
Group B: primary sjogren's
Group C: secondary sjogren's
Trial outcomes
Primary outcomes
1
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
following the natural history of Sjogren's disease progression.
Time frame
patients are followed up to 10 yearsSecondary outcomes
1
1. To establish a teaching cohort of patients with SjD or SjD-like conditions treated with conventional treatments 2. To identify patients for other protocols related to Sjogren's Disease
Time frame
OngoingSponsors and contacts
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Source ClinicalTrials.gov