Development of a Novel Human In Vitro Sarcoidosis Model
1 other identifier
observational
60
1 country
1
Brief Summary
There is currently no experimental model that accurately represents sarcoidosis. The lack of a useful research model significantly slows progress towards developing new treatments for sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will test the model to see if it helps us understand how sarcoidosis develops and if it is useful for testing new treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2012
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2017
CompletedNovember 3, 2021
November 1, 2021
4.1 years
May 2, 2013
November 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Sarcoidosis patients, volunteers with latent TB, and healthy volunteer subjects will be recruited to donate peripheral blood for isolation of peripheral blood mononuclear cells.
We hypothesize that patients with the active sarcoidosis phenotype will exhibit accelerated granuloma formation with higher IL-10(IL Interleukin)and IL-4 expression relative to patients with the self-limited sarcoidosis phenotype
2-4 years
Study Arms (1)
Observational study
Blood draw only, observational study
Interventions
No intervention. We are collecting blood for an ex vivo study
Eligibility Criteria
primary care clinic
You may qualify if:
- sarcoidosis, subjects (18 - 45 years of age), including 30 sarcoidosis, 15 latent TB and 15 healthy controls.
You may not qualify if:
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biomedical Research Tower, 10th floor
Columbus, Ohio, 43221, United States
Related Publications (2)
Locke LW, Crouser ED, White P, Julian MW, Caceres EG, Papp AC, Le VT, Sadee W, Schlesinger LS. IL-13-regulated Macrophage Polarization during Granuloma Formation in an In Vitro Human Sarcoidosis Model. Am J Respir Cell Mol Biol. 2019 Jan;60(1):84-95. doi: 10.1165/rcmb.2018-0053OC.
PMID: 30134122DERIVEDCrouser ED, White P, Caceres EG, Julian MW, Papp AC, Locke LW, Sadee W, Schlesinger LS. A Novel In Vitro Human Granuloma Model of Sarcoidosis and Latent Tuberculosis Infection. Am J Respir Cell Mol Biol. 2017 Oct;57(4):487-498. doi: 10.1165/rcmb.2016-0321OC.
PMID: 28598206DERIVED
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elliott Crouser, MD
Ohio State University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Internal Medicine
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 20, 2013
Study Start
December 19, 2012
Primary Completion
February 2, 2017
Study Completion
February 2, 2017
Last Updated
November 3, 2021
Record last verified: 2021-11