Sarcoidosis, PulmonaryRISE-UPNCT05567133
Risk Indicators of Sarcoidosis Evolution-Unified Protocol
An observational study of Sarcoidosis, Pulmonary, run by University of California, San Francisco at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2023to 30 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: adults who meet criteria for the diagnosis of pulmonary sarcoidosis
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Cardenas contact
United States2 sites, 2 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Wonder P Drake, MD, wdrake@som.umaryland.edu
- Recruiting
UT Southwestern
Dallas, Texas, 75390
Fabiola Gianella, 214-648-7875, Fabiola.Gianella@UTsouthwestern.edu
About this study
Official title: Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
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
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- sarcoid, lung, immune
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start10 Jan 2023
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Laura Koth, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567133
- Sponsor's protocol ID
- P0551258
- Other IDs
- R01HL157533
- Acronym
- RISE-UP
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
- ClinicalTrials.gov ID
- NCT05567133
- Acronym / sponsor ID
- RISE-UP / P0551258
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- sarcoid, lung, immune
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of Texas, Southwestern Medical Center at Dallas, Wayne State University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults who meet criteria for the diagnosis of pulmonary sarcoidosis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 37012011Drake 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Cardenas contact
Laura Koth principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, Pulmonary, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Koth (4155144369, laura.koth@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Forced Vital Capacity in Liters (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026; AzTrials last refreshed its copy on 5 Nov 2026.