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Penn SICCA Follow-up Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "In addition, specimens such as biopsies, saliva, sera, conjunctival cells, and tears will be collected."
  • "Standardized questionnaires will be used to gain health information."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects follow-up health information and samples from people who were in the SICCA study at Penn and had test results showing dry eyes. It includes people with or without Sjogren's syndrome, a disease that can cause dry eyes and dry mouth. Study visits include mouth, eye, and physical exams, tests for dryness, and sometimes a small tissue sample from inside the lip.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You previously took part in the SICCA study at Penn.
  • You are 18 or older.
  • You have signed a consent form agreeing to the study's terms.

Who can't join

  • You did not previously take part in the SICCA study at Penn.
  • You are younger than 18.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

PA