Clinical trial NCT05567133: Risk Indicators of Sarcoidosis Evolution-Unified Protocol
Official title: Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoidosis, Pulmonary
Keywords: sarcoid, lung, immune
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: University of Texas, Southwestern Medical Center at Dallas
name: Wayne State University
First posted: 2022-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults who meet criteria for the diagnosis of pulmonary sarcoidosis

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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%

Primary outcomes:
measure: Mean Change in Forced Vital Capacity in Liters
timeFrame: Baseline and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Laura Koth
role: PRINCIPAL_INVESTIGATOR
References: