- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03769987
Registry for Advanced Sarcodiosis (REAS)
December 6, 2018 updated by: Robert P Baughman, University of Cincinnati
Registry for Advanced Sarcoidosis
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis
Study Overview
Study Type
Observational
Enrollment (Anticipated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robert Baughman
- Phone Number: 513-584-5225
- Email: bob.baughman@uc.edu
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- Recruiting
- University of Cincinnati
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 98 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Advanced sarcoidosis is defined by the presence of one or more of the following features:
- Advanced pulmonary disease as defined by one or more of the following
- Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and
- Symptomatic neurologic disease
- Patients who have received third line therapy (anti-TNF antibodies, rituximab, or RCI)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 2 years
|
Determine how many people die during follow up
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Robert Baughman, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
June 30, 2020
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
December 6, 2018
First Posted (Actual)
December 10, 2018
Study Record Updates
Last Update Posted (Actual)
December 10, 2018
Last Update Submitted That Met QC Criteria
December 6, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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