Risk Indicators of Sarcoidosis Evolution-Unified Protocol | NCT05567133

Studies
Risk Indicators of Sarcoidosis Evolution-Unified Protocol

NCT05567133

Sponsor

University of California, San Francisco

Status

Recruiting

Last Update Posted

Jan 8, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Sarcoidosis, Pulmonary

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL157533	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2023Actual

Primary Completion Date

Mar 30, 2030Estimated

Completion Date

Mar 30, 2030Estimated

First Submitted Date

Sep 30, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 8, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of California, San FranciscoOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adults who meet criteria for the diagnosis of pulmonary sarcoidosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura Koth	Contact	4155144369		laura.koth@ucsf.edu
Jessica Cardenas	Contact			jessica.cardenas@ucsf.edu

Overall Officials

Name	Affiliation	Role
Laura Koth	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland	Recruiting	Baltimore	Maryland	21201	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37012011	Derived	Drake WP, Hsia C, Samavati L, Yu M, Cardenas J, Gianella FG, Boscardin J, Koth LL. Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP): protocol for a multi-centre, longitudinal, observational study to identify clinical features that are predictive of sarcoidosis progression. BMJ Open. 2023 Apr 3;13(4):e071607. doi: 10.1136/bmjopen-2023-071607.

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D008232	Lymphoproliferative Disorders

ID	Term
D017565	Sarcoidosis, Pulmonary
D012507	Sarcoidosis