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RISE-UP: Risk Indicators of Sarcoidosis Evolution-Unified Protocol

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05567133
Collaborator
Vanderbilt University Medical Center (Other), University of Texas, Southwestern Medical Center at Dallas (Other), Wayne State University (Other)
200
Enrollment
2
Locations
42
Anticipated Duration (Months)
100
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
    Anticipated Study Start Date :
    Sep 28, 2022
    Anticipated Primary Completion Date :
    Mar 30, 2026
    Anticipated Study Completion Date :
    Mar 30, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt Medical Center Nashville Tennessee United States 37232
    2 UT Southwestern Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of California, San Francisco
    • Vanderbilt University Medical Center
    • University of Texas, Southwestern Medical Center at Dallas
    • Wayne State University

    Investigators

    • Principal Investigator: Laura Koth, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05567133
    Other Study ID Numbers:
    • P0551258
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Oct 5, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco
    sarcoid, lung, immune
    Additional relevant MeSH terms:
    Sarcoidosis, Pulmonary
    Sarcoidosis

    Study Results

    No Results Posted as of Oct 5, 2022