NCT01857401

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2017

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

4.1 years

First QC Date

May 2, 2013

Last Update Submit

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

Other: No intervention, observational study only

Interventions

No intervention. We are collecting blood for an ex vivo study

Observational study

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Location

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.

  • Crouser 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Elliott Crouser, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

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

Locations