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Protocol Details

Sjogren's Team for Accelerating Medicines Partnership (STAMP)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 79 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Sjogren Syndrome

Recruitment Keyword(s)



Healthy Volunteers;
Sjogren's Syndrome;
Salivary Gland Diseases;
Immune System Diseases

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Dental and Craniofacial Research

Sjogren s disease (SjD) is an autoimmune disorder that affects the glands that produce saliva and tears. People with SjD are also at risk for cancers such as lymphoma. SjD is poorly understood and has few treatment options.


To improve understanding of SjD, determine its cause, and seek treatments for it.


The NIH is enrolling only healthy volunteers, aged 18 years or older, for this study.


Participants will have 1 visit to the NIH clinic.

They will have a physical exam and provide blood and urine samples.

They will have an examination of the mouth. They will provide 2 saliva samples. For one, they will drool into a tube for 5 minutes. For the other, 2 suction cups will be placed on the inner surfaces of their cheeks, and a tart solution will be placed on the tongue every 30 seconds for 5 minutes.

They will have a lip biopsy. The area will be numbed, and an incision less than a half inch long will be made on the inner surface of their lower lip.

They will have an ultrasound exam of their salivary glands. A wand will be placed on the skin behind the jaw to capture images of the glands.

They will have an eye exam to test for dryness. A strip of filter paper will be placed inside each lower eyelid to capture tears. Their eyes will be stained with a green dye to assess the effects of any dryness on the structure of the eye.

They may take a stool collection kit home to send in a sample by mail.

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18 years of age or older

At least one of the following characteristics:

a. Complaint of dry eyes/mouth (positive response to AECG questions)

b. Previous diagnosis of SjD

c. Bilateral parotid enlargement consistent with SjD

d. Multiple cervical or incisal dental caries (absence of other risk factors)

e. Abnormal serology suggestive of systemic autoimmune disorder (i.e., elevated RF, ANA (>1:320 titer), anti-Ro/SSA, anti-La/SSB)

Signed IRB consent form agreeing to study terms

Adding the following to the Inclusion Criteria for the NIH site

- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied.

- Sponsor Inclusion criteria listed under section C 1.2 Eligibility Criteria, the NIH site will allow enrollment of Healthy Control Cohort group with known past SARS-CoV-2 infection.


<18 years of age

Treatment with immune checkpoint inhibitor for neoplastic disease

Use of anticholinergic medications (if only entry criterion is "dry mouth")

Past head and neck radiation treatment

Dry eyes secondary to corneal surgery, rosacea, or chronic blepharitis or other known systemic diseases or comorbidities other than SLE or RA

Anatomical or neurological lid closure problems (e.g., Bell's palsy, cicatricial ectropion, Parkinson's)

Physical or mental condition interfering with the successful participation in this study

Pre-existing diagnosis of a systemic auto-immune rheumatic disease (SARD) other than SLE or RA

Prior diagnosis of Hepatitis C infection (HCV); HIV infection; Sarcoidosis; Amyloidosis; Tuberculosis; IgG4-related disease; Graft versus host disease; Cicatrizing conjunctivitis (e.g. from trachoma, Stevens-Johnson syndrome, pemphigoid, drug induced pseudo-pemphigoid, or chemical ocular burns)

Adding to the Exclusion Criteria for the NIH site:

-The NIH Principal Investigator (PI) and NIH employees who report directly to the NIH PI

- Direct family members of the NIH PI and of NIH employees who directly report to the NIH PI

- 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.

- Sicca Symptoms

- HIV, hepatitis B or C infection

- Chronic medical illness, other than well-controlled hypertension or hyperlipidemia

- Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Blake M. Warner, D.D.S.
National Institute of Dental And Craniofacial Research (NIDCR)
(301) 500-8063

Regina Marie Tabios Reyes
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 10
Room 1N113
10 Center Drive
Bethesda, Maryland 20892
(301) 201-8628

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

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