Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05056012

Penn SICCA Follow-up Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dry Eye Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously participated in the SICCA study at Penn
  • Be 18 years or older
  • 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

Treatment and study plan

Primary outcomes

  1. 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

  1. Ocular surface exam findings

    Time frame: 2 years

    Characterize the clinical features of the ocular and oral components of dry eye patients with or without Sjogren's syndrome.

  2. Serologic testing

    Time frame: 2 years

    Characterize the laboratory, including serologic (including autoantibodies), features of dry eye patients with or without Sjogren's syndrome.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Iacobucci

CONTACT

[email protected]

215-662-9393

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Penn Sjögren's International Clinical Collaborative Alliance (SICCA) Follow-up Study

Acronym: PSFS

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 24, 2021
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.