Registry for Advanced Sarcodiosis

NCT03769987 | Unknown

• 1 other identifier: REAS
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoidosis

Keywords

neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin

Outcome Measures

Primary Outcomes (1)

• Death

  Determine how many people die during follow up

  2 years

Interventions

observation OTHER

observe patients every 6 months

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Neurosarcoidosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Robert Baughman

  University of Cincinnati

  STUDY CHAIR

Central Study Contacts

Robert Baughman

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)