NCT05567133

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2023Mar 2030

First Submitted

Initial submission to the registry

September 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2030

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

7.2 years

First QC Date

September 30, 2022

Last Update Submit

January 6, 2026

Conditions

Keywords

sarcoid, lung, immune

Outcome Measures

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.

    Baseline and 24 months

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults who meet criteria for the diagnosis of pulmonary sarcoidosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

UT Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for serum isolation

MeSH Terms

Conditions

Sarcoidosis, PulmonarySarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Laura Koth

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Cardenas

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 5, 2022

Study Start

January 10, 2023

Primary Completion (Estimated)

March 30, 2030

Study Completion (Estimated)

March 30, 2030

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations