Risk Indicators of Sarcoidosis Evolution-Unified Protocol

Recruiting

• Conditions: Sarcoidosis, Pulmonary

• Registration Number: NCT05567133
• Lead Sponsor: University of California, San Francisco

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

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Study Start: 2023-01-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change in Forced Vital Capacity in Liters	Baseline and 24 months	Forced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver.

Trial Locations

Locations (2)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

UT Southwestern; 🇺🇸 Dallas, Texas, United States