Foundation launches sarcoidosis research registry across 13 US sites
Effort will support high-quality, standardized clinical data collection
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The Foundation for Sarcoidosis Research (FSR) has selected more than a dozen clinical centers to serve as inaugural sites for its newly launched U.S.-based registry that aims to enroll at least 2,000 people with sarcoidosis.
The FSR Clinical Data Registry will help support high-quality, standardized clinical data collection for research aimed at improving care for people with the inflammatory disease.
“Sarcoidosis has remained a mystery for over 150 years,” Mary McGowan, president and CEO of FSR, said in a foundation press release. “We can [no] longer wait for progress; we must aggressively and actively generate tools and strategies to lay the groundwork for acceleration of research, clinical care, therapy development and patient outcomes.”
Disease progression, other factors to be evaluated every 6 months
Eligible participants are those 18 years and older with sarcoidosis, including that affecting organs other than the lungs, who have established care in one of the participating centers within the past two to four years.
Patients will be evaluated every six months starting from their entry in the registry. Evaluated outcomes include disease progression, hospital-related outcomes, death, new organ involvement, patient-reported outcomes, and treatment initiation and response.
The registry’s main goals include defining the spectrum of sarcoidosis clinical profiles, describing the frequency of sarcoidosis manifestations and treatment patterns, and documenting the frequency of side effects of treatments.
“FSR is proud to pioneer this groundbreaking research effort to build the most comprehensive multi-disciplinary, multi-institute data set in sarcoidosis ever created,” McGowan said. “Through this collective effort, we are certain that the next 5-7 years will yield some of the most important discoveries for the field of sarcoidosis and beyond.”
Centers selected based on expertise, ease of access by diverse people
A total of 13 centers were selected in part based on available expertise, as well as other factors like ensuring that the registry can be accessed by diverse people with sarcoidosis across the U.S. In the coming months, the FSR will be formalizing agreements and working to launch the program at each of the following centers:
- Brigham and Women’s Hospital
- Cedars-Sinai Medical Center
- Duke University
- Medical University of South Carolina
- Hospital for Special Surgery
- National Jewish Health
- New York University’s Grossman School of Medicine
- The Ohio State University
- Stanford University
- University of Minnesota
- University of Virginia
- University of Texas Southwestern
- Yale University
“Every sarcoidosis patient has a unique journey,” said Mridu Gulati, MD, co-chair of the registry’s steering committee from Yale University. “The FSR multicenter Clinical Data Registry provides a critical opportunity to capture these [individuals’] stories and transform them into data that will inform more effective management and treatment decisions, ultimately improving the well-being of current and future sarcoidosis communities.”
Drawing on insights from expert working groups, including patients, caregivers, healthcare providers, and pharmaceutical companies, FSR has developed a distinctive protocol and data collection approach for the new registry that is designed to deepen understanding of the multidisciplinary nature of sarcoidosis.
“The FSR Clinical Data Registry is a long-awaited opportunity to bring a large-scale multi-center study to this rare devastating disease to help us better understand its presentations, manifestations and outcomes across the US,” said Lisa Maier, MD, co-chair of the registry’s steering committee from National Jewish Health. “Other rare lung diseases have benefited from having similar studies to help advance the understanding of the natural history of disease, and ultimately how treatments could help prevent impairment – with this new study, we will now be able to use this registry to advance understanding and interventions to address this severe [body-wide] disease.”
The new clinical data registry will complement the FSR-SARC Patient Registry, a separate program from the FSR that collects patient-reported findings from people with sarcoidosis worldwide.
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