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

Status

Unknown

Conditions

Intervention / Treatment

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

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:

  1. Advanced pulmonary disease as defined by one or more of the following
  2. Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and
  3. Symptomatic neurologic disease
  4. 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.

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

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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