Risk Indicators of Sarcoidosis Evolution-Unified Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2030-03-30

Brief Summary

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The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.

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Detailed Description

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The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.

Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.

Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.

The investigators will measure two types of blood markers to achieve this goal:

* Clinically available blood markers that are available in most clinical labs
* Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs

Conditions

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Sarcoidosis, Pulmonary

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults with a diagnosis of sarcoidosis over the age of 18
2. Case definition: we will follow the 1999 statement on sarcoidosis published by the American Thoracic Society for diagnosis which includes tissue biopsy confirmation and exclusion of alternative diagnoses including beryllium sensitization/chronic beryllium disease, mycobacterial, viral, and/or fungal infection

Exclusion Criteria

1. Inability to tolerate study procedures as determined by the investigator
2. Pregnant or breastfeeding
3. Concurrent medical diagnoses that would influence the expression of biomarkers will be considered an exclusion criterion. This includes diseases such as common variable immunodeficiency, HIV infection, or autoimmune diseases
4. Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis
5. Hematocrit (Packed Cell Volume) \< 25%

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No