Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients. The research will look into identifying and validating cGVHD biological indicators (=bio-markers) which will be evaluated whether they can predict a future development of the disease. The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be present at the time of cGVHD diagnosis, will also be present at earlier time points, before cGVHD develops. Following validation, the bio-markers will be beneficial for finding those patients who are in higher risk to develop cGVHD. By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive therapy might be applied in order to prevent or reduce the prevalence of the disease.
Study Type
OBSERVATIONAL
Enrollment
302
Children's of Alabama
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Nemours A. I. DuPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
C S Mott Children's Hospital The University of Michigan
Ann Arbor, Michigan, United States
...and 15 more locations
Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients
The study will try to determine the prevalence (or levels) of high-probability predictive plasma and cellular cGVHD bio-markers in pediatric patients undergoing allogeneic HSCT from blood samples
Time frame: Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months
Validation of "predictive" cGVHD bio-markers
To determine and validate whether "predictive" cGVHD bio-markers present before the onset of cGVHD are able to predict a subset of pediatric patients at greatest risk for the development of cGVHD in the future
Time frame: Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017)
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