Clinical trial NCT05056012: Penn SICCA Follow-up Study
Official title: Penn Sjögren's International Clinical Collaborative Alliance (SICCA) Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dry Eye
Sjogren's Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who meet the inclusion/exclusion criteria for this study will be contacted to ask if they would be willing to participate. All recruited participants, who participated in the previous SICCA study at the University of Pennsylvania will be identified.

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.

Eligibility criteria: Inclusion Criteria:

1. Previously participated in the SICCA study at Penn
2. Be 18 years or older

4. Have signed an IRB consent form agreeing to the terms of the study

Exclusion Criteria:

1. Did not previously participate in SICCA study at Penn
2. Under the age of 18 years

Primary outcomes:
measure: Collection of specimens and clinical information
timeFrame: 2 years
Secondary outcomes:
measure: Ocular surface exam findings
timeFrame: 2 years
measure: Serologic testing
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
Study officials:
affiliation: Scheie Eye Institute
name: Vatinee Bunya, MD
role: PRINCIPAL_INVESTIGATOR
References: