CClinicalTrials.gg
RecruitingNCT05567133RISE-UPUpdated Jan 8, 2026

Risk Indicators of Sarcoidosis Evolution-Unified Protocol

An observational study in Sarcoidosis, Pulmonary, sponsored by University of California, San Francisco. Recruiting at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by University of California, San Francisco · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
200
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Sarcoidosis, Pulmonary

Keywords

  • sarcoid, lung, immune
03

In context

Sarcoidosis, Pulmonary

63 studies on the registry are indexed under Sarcoidosis, Pulmonary; 15 are open to participants now.

This study's planned enrollment of 200 is above the median of 84 across 14 observational studies indexed under Sarcoidosis, Pulmonary.

Browse Sarcoidosis, Pulmonary studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adults who meet criteria for the diagnosis of pulmonary sarcoidosis

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

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%
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 24 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • 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. PubMed 37012011 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05567133
Lead sponsor
University of California, San Francisco
Collaborators
Vanderbilt University Medical Center, University of Texas, Southwestern Medical Center at Dallas, Wayne State University, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 5, 2022
Start date
Jan 10, 2023
Primary completion
Mar 30, 2030 (estimated)
Completion
Mar 30, 2030 (estimated)
Last update
Jan 8, 2026

Study contacts

Laura Koth
Contact
laura.koth@ucsf.edu
4155144369
Jessica Cardenas
Contact
jessica.cardenas@ucsf.edu
Laura Koth
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion