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Development of a Novel Human In Vitro Sarcoidosis Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01857401
Recruitment Status : Unknown
Verified September 2014 by Elliott Crouser MD, Ohio State University.
Recruitment status was:  Recruiting
First Posted : May 20, 2013
Last Update Posted : September 4, 2014
Information provided by (Responsible Party):
Elliott Crouser MD, Ohio State University

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.

Condition or disease Intervention/treatment
Sarcoidosis Other: No intervention, observational study only

Detailed Description:

Sarcoidosis is a systemic granulomatous disease of unknown cause, most commonly affecting the lungs, which tends to afflict young adults in the prime of their lives. Recent data indicating that sarcoidosis mortality rates are rising in the U.S. (1) and Europe (2) highlight the inadequacy of current therapies. As noted in a recent NIH-sponsored sarcoidosis workshop, the lack of relevant animal, computer or in vitro models represents a bottleneck for progress towards understanding disease mechanisms and developing highly effective sarcoidosis treatments (3). The lack of useful disease models likely contributes to the current lack (zero) of investigator-initiated (RO1) projects supporting sarcoidosis research.

The long-term goal of this proposal is to develop a novel human sarcoidosis research model to fill the current void in the field, thereby expediting exploration of basic disease mechanisms and pre-clinical testing of novel therapies. The objective of this application, which is the first step towards achieving the long-term goal, is to develop a novel in vitro human granuloma model to represent abnormal granuloma formation in the context of sarcoidosis. In this regard, a growing body of evidence indicates that mycobacterial antigens are commonly harbored in sarcoidosis tissues, to which these patients are sensitized (4, 5). Our central hypothesis is that the pathological mechanisms of sarcoidosis can be modeled in vitro, as represented by abnormal granuloma formation in response to mycobacterial and other ubiquitous environmental antigens. The feasibility of our proposed model is supported by preliminary studies showing that subjects sensitized to Mycobacterium tuberculosis antigens (latent TB tuberculosis with a positive TB skin test) form well-organized granulomas readily in response to challenge with TB antigens, compared to healthy controls. This project is highly innovative and we feel has an excellent likelihood of leading to a critical breakthrough in the field of sarcoidosis research.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Novel Human In Vitro Sarcoidosis Model
Study Start Date : April 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Group/Cohort Intervention/treatment
Observational study
Blood draw only, observational study
Other: No intervention, observational study only
No intervention. We are collecting blood for an ex vivo study

Primary Outcome Measures :
  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. [ Time Frame: 2-4 years ]
    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

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primary care clinic

Inclusion Criteria:

  • sarcoidosis, subjects (18 - 45 years of age), including 30 sarcoidosis, 15 latent TB and 15 healthy controls.

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01857401

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Contact: Elliot Crouser, MD 6147-293-4975

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United States, Ohio
Biomedical Research Tower, 10th floor Recruiting
Columbus, Ohio, United States, 43221
Contact: Elliot Crouser, MD    614-293-4978   
Principal Investigator: Elliot Crouser, MD         
Sponsors and Collaborators
Elliott Crouser MD
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Principal Investigator: Elliott Crouser, MD Ohio State University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Elliott Crouser MD, Assistant Professor of Internal Medicine, Ohio State University Identifier: NCT01857401    
Other Study ID Numbers: 2012H0073
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases