Penn Sjögren's International Clinical Collaborative Alliance (SICCA) Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Collection of specimens and clinical information
Study Overview
Brief Summary
This study will involve the collection of follow-up data for patients who previously participated in the Sjogren's International Clinical Collaborative Alliance (SICCA) study at the University of Pennsylvania. Clinical data and specimens will be collected from subjects with objective evidence of dry eye who were or were not diagnosed with Sjogren's syndrome at the time of their initial participation in the SICCA study. Specimens will be collected from participants which will include tears, saliva, whole blood, serum, DNA and possible labial minor salivary gland biopsies when indicated. All individuals will participate in a standard evaluation protocol including an oral, ocular and physical examination, objective tests for dry eyes and dry mouth and, whenever necessary, a labial minor salivary gland biopsy. The biopsy requirement is waived for those who have already had positive lip biopsies in the past.
Detailed Description
General study design: This is a single center study that involves follow-up of patients who previously participated in the Sjogren's International Collaborative Clinical Alliance (SICCA) at the University of Pennsylvania. Objective evaluation of salivary function will be done by collecting unstimulated whole and stimulated parotid saliva. Objective evaluation of lacrimal function will be performed using the Schirmer test I, Lissamine Green staining, and determining tear break-up time. In a subset of patients, when indicated an objective evaluation of lymphocytic infiltration of the minor salivary glands will be performed by histologic analysis of labial salivary gland biopsies. Serum autoantibody profiles will be determined. In addition, specimens such as biopsies, saliva, sera, conjunctival cells, and tears will be collected. Standardized questionnaires will be used to gain health information.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previously participated in the SICCA study at Penn
- •Be 18 years or older
- •4. Have signed an IRB consent form agreeing to the terms of the study
Exclusion Criteria
- •Did not previously participate in SICCA study at Penn
- •Under the age of 18 years
Outcomes
Primary Outcomes
Collection of specimens and clinical information
Time Frame: 2 years
To collect specimens (saliva, tears, conjunctival cells, and blood) and clinical information on dry eye patients with or without Sjogren's syndrome
Secondary Outcomes
- Serologic testing(2 years)
- Ocular surface exam findings(2 years)
Investigators
Vatinee Bunya, MD
Co-Director of Penn Dry Eye & Ocular Surface Center
University of Pennsylvania