Skip to content

Risk Indicators of Sarcoidosis Evolution-Unified Protocol

Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05567133
Acronym
RISE-UP
Enrollment
200
Registered
2022-10-05
Start date
2023-01-10
Completion date
2030-03-30
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis, Pulmonary

Keywords

sarcoid, lung, immune

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

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
CollaboratorOTHER
University of Texas, Southwestern Medical Center at Dallas
CollaboratorOTHER
Wayne State University
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum

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%

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Forced Vital Capacity in LitersBaseline and 24 monthsForced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver.

Countries

United States

Contacts

Primary ContactLaura Koth
laura.koth@ucsf.edu4155144369
Backup ContactJessica Cardenas
jessica.cardenas@ucsf.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026