Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
- Conditions
- cGVHD
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT05919511
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Age ≥ 18 years inclusive at the time of signing the ICF
- Allogeneic SCT 90 to 180 days prior to enrollment
- Able to comprehend and willing to provide informed consent
- Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
- There are no exclusion criteria for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description At risk for GVHD Non-Interventional Equal or Greater than 18 years old post alloSCT
- Primary Outcome Measures
Name Time Method Overall Burden of cGVHD diagnosis and severity 36 months
- Secondary Outcome Measures
Name Time Method To describe personal and healthcare resources associated with the management of cGVHD 36 months To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD Up to 36 months
Trial Locations
- Locations (25)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
City of Hope
🇺🇸Duarte, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Group
🇺🇸Chicago, Illinois, United States
Massachusetts Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
The University of Kansas Clinical Research Center
🇺🇸Fairway, Kansas, United States
Tulane Cancer Center
🇺🇸New Orleans, Louisiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Utah, Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States