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The Pathogenesis and Natural History of Sjogren s Syndrome
This study is currently recruiting participants.
Verified April 19, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier:
NCT01425892
First received: August 27, 2011
Last updated: June 30, 2017
Last verified: April 19, 2017
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Purpose
Background:
-Sjogren 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 syndrome is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s syndrome.
Objectives:
-To better understand how Sjogren s syndrome 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 syndrome or have at least two symptoms of Sjogren s syndrome.
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.
| Condition |
|---|
| Pathogenesis Sjogren's Syndrome Salivary Gland |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Pathogenesis and Natural History of Sjogren s Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
Sjögren syndrome
MedlinePlus related topics:
Sjogren's Syndrome
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Primary Outcome Measures:
- Clinical phenotyping of SS patients and controls over time; Collection of samples for concurrent and future laboratory studies related to the pathogenesis; Identification of biomarker candidates in SS
Secondary Outcome Measures:
- To establish a teaching cohort of patients with SS or SS-like conditions treated with conventional treatments; To identify patients for other protocols related to Sj(SqrRoot)(Delta)gren's Syndrome
- To identify patients for other protocols related to Sjogren's Syndrome
| Estimated Enrollment: | 300 |
| Study Start Date: | July 29, 2011 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
-
INCLUSION CRITERIA:
- Ability to sign informed consent form
-
Fulfilling one the definitions below:
- Sj(SqrRoot)(Delta)gren s defined by European-American (EA) classification criteria for primary or secondary Sj(SqrRoot)(Delta)gren s syndrome (SS group)
- Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SS group)
- Incomplete SS
i. at least 2 of the EA criteria with a common manifestation of SS not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc)
ii. 2 or more common manifestations of SS 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:
- 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..
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425892
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425892
Contacts
| Contact: Lauren M Long, R.N. | (301) 594-1644 | longl@mail.nih.gov | |
| Contact: Ilias G Alevizos, D.M.D. | (301) 496-6207 | alevizosi@mail.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
| Principal Investigator: | Ilias G Alevizos, D.M.D. | National Institute of Dental and Craniofacial Research (NIDCR) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Dental and Craniofacial Research (NIDCR) |
| ClinicalTrials.gov Identifier: | NCT01425892 History of Changes |
| Other Study ID Numbers: |
110172 11-D-0172 |
| Study First Received: | August 27, 2011 |
| Last Updated: | June 30, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
|
Salivary Gland Pathogenesis Sj(SqrRoot)(Delta)gren s Syndrome Sjogren Syndrome |
Additional relevant MeSH terms:
|
Syndrome Sjogren's Syndrome Disease Pathologic Processes Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on August 21, 2017