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Protocol Details

The Pathogenesis and Natural History of Sjogren's Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-D-0172

Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 16 Years
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Sjogren's Syndrome;
Salivary Gland;
Pathogenesis;
Natural History;
Healthy Volunteer

Recruitment Keyword(s)

None

Condition(s)

Sjogren's Syndrome;
Salivary Gland;
Pathogenesis;
Healthy Volunteer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Dental and Craniofacial Research

Background:

-Sjogren s Disease 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.

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Eligibility

INCLUSION CRITERIA:

1. Ability to sign informed consent form

2. Fulfilling one the definitions below:

a. Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)

b. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)

c. 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:

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Zohreh Khavandgar, D.D.S.
National Institute of Dental And Craniofacial Research (NIDCR)
NIHBC 10 - CLINICAL CENTER BG RM 1N110
10 CENTER DR
BETHESDA MD 20892
(301) 496-4486
zohreh.khavandgar@nih.gov

Eileen M. Pelayo
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 10
Room 1N110
10 Center Drive
Bethesda, Maryland 20892
(301) 594-3097
eileen.pelayo@nih.gov

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
ccopr@nih.gov

Clinical Trials Number:

NCT01425892

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