Recruiting

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT03769987

Conditions

Sarcoidosis

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

Interventions

observation

Study Details

Brief summary:

Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis

Conditions

Sarcoidosis

Study ID

NCT03769987

Start date

Jan 1, 2017

Status verified date

Dec, 2018

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria

  • Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22
  • Age ≥ 18 years.
  • Life expectancy of at least 2 years.
  • Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary function testing on the day of study enrollment
  • Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition of advanced disease)
  • Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Exclusion criteria

  • Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
  • Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Interventions

observation

observe patients every 6 months

Primary outcome measure

  • Death [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Robert Baughman

513-584-5225bob.baughman@uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Robert P Baughman, MD

513-584-5225bob.baughman@uc.edu

Elyse E Lower

513-584-3829ELower@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Dec 10, 2018

Last verified

Dec, 2018

Keywords

  • neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2018-12-10.