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NCT Number: NCT05567133

Risk Indicators of Sarcoidosis Evolution-Unified Protocol

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland, Baltimore, Maryland, United States

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with a diagnosis of sarcoidosis over the age of 18
  • 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

  • Inability to tolerate study procedures as determined by the investigator
  • Pregnant or breastfeeding
  • 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
  • Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis
  • Hematocrit (Packed Cell Volume) < 25%

Treatment and study plan

Primary outcomes

  1. Mean Change in Forced Vital Capacity in Liters

    Time frame: Baseline and 24 months

    Forced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Cardenas

CONTACT

[email protected]

Laura Koth

CONTACT

[email protected]

4155144369

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Texas, Southwestern Medical Center at Dallas
  • Vanderbilt University Medical Center
  • Wayne State University

Registry information

Official study title

Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis

Acronym: RISE-UP

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Oct 5, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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