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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03769987
Other study ID # REAS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date June 30, 2020

Study information

Verified date December 2018
Source University of Cincinnati
Contact Robert Baughman
Phone 513-584-5225
Email bob.baughman@uc.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date June 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
observation
observe patients every 6 months

Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death Determine how many people die during follow up 2 years
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