Risk Indicators of Sarcoidosis Evolution-Unified Protocol

Sarcoidosis, Pulmonary Clinical Trial

— RISE-UP  

Official title:

Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567133
• Other study ID #: P0551258
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: May 2023
• Source: University of California, San Francisco
• Contact: Laura Koth
• Phone: 4155144369
• Email: laura.koth[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Gender: All
• Age group: 19 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	UT Southwestern	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Texas, Southwestern Medical Center at Dallas, Vanderbilt University Medical Center, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Forced Vital Capacity in Liters	Forced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver.	Baseline and 24 months