Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry for Advanced Sarcodiosis (REAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769987
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Brief Summary:
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis

Condition or disease Intervention/treatment
Sarcoidosis Other: observation

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry for Advanced Sarcoidosis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis


Intervention Details:
  • Other: observation
    observe patients every 6 months


Primary Outcome Measures :
  1. Death [ Time Frame: 2 years ]
    Determine how many people die during follow up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769987


Contacts
Layout table for location contacts
Contact: Robert Baughman 513-584-5225 bob.baughman@uc.edu

Locations
Layout table for location information
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD    513-584-5225    bob.baughman@uc.edu   
Contact: Elyse E Lower    513-584-3829    ELower@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Investigators
Layout table for investigator information
Study Chair: Robert Baughman University of Cincinnati

Additional Information:

Layout table for additonal information
Responsible Party: Robert P Baughman, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03769987     History of Changes
Other Study ID Numbers: REAS
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert P Baughman, University of Cincinnati:
neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin

Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases