Solid organ transplantation is an important therapeutic option for children with a variety of end stage diseases. However, the same immunosuppressive medications that are required to prevent the child's immune system from attacking and rejecting the transplanted organ can predispose these individuals to developing a very serious cancer that is linked to Epstein-Barr virus (EBV).
Name: transplant
Description: All subjects enrolled in this study are candidates for/recipients of solid organ transplants as a therapeutic for end stage diseases (e.g., heart, liver, heart with liver, kidney, small intestine, or liver with small intestine transplants).Type: ProcedureSubjects Enrolled Post-Transplant Subjects Enrolled Pre-Transplant
Name: Immunosuppressive Drugs
Description: Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.Type: DrugSubjects Enrolled Post-Transplant Subjects Enrolled Pre-Transplant
Description: The development of EBV positive PTLD during the study period as assessed by the local site pathologist, with confirmation of the PTLD diagnosis by the Study Clinicopathological Review Board (SCPRB)
Measure: Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD) Time: Receipt of transplanted organ(s) to confirmation of EBV-positive PTLD, up to year 4 post - enrollmentDescription: Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method
Measure: Specified Gain-of-Function Mutations in EBV Latent Membrane Protein 1 (LMP-1) Time: Receipt of transplanted organ(s) to confirmation of mutations in EBV LMP1 , up to year 4 post - enrollmentDescription: Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)
Measure: Pathogenic Changes in B Cell Clonotype Development Time: Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollmentCase-Control
There are 2 SNPs
Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method. --- G212S ---
Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method. --- G212S --- --- S366T ---