An observational study in Heart Transplant, Small Intestine Transplant and Kidney Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 7 sites in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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).
EBV-associated post-transplant lymphoproliferative disease (PTLD) is the most common malignancy in children after transplant. Diagnosis and effective treatment of the EBV-associated cancer is hampered by our inability to determine which children are at risk of developing these cancers and to detect the cancer at an early stage. In this study, we plan to test new "biomarkers" in the blood of children that will tell us very early on if the child is at risk of developing the EBV-associated cancer or if the cancer is present. These studies provide new opportunities for detection, diagnosis, and treatment of children with EBV-associated, post-transplant cancer.
231 studies on the registry are indexed under Lymphoproliferative Disorders; 45 are open to participants now.
This study's enrollment of 944 is above the median of 241 across 37 observational studies indexed under Lymphoproliferative Disorders.
Browse Lymphoproliferative Disorders studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric Candidates for or recipients of heart, liver, heart with liver, kidney, small intestine, or liver with small intestine at participating major pediatric solid organ transplant programs
Exclusion Criteria:
Subjects (N=approximately 357) Enrolled Pre-Transplant * Subjects with evidence of EBV infection prior to transplant * Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
Procedure: transplant · Drug: Immunosuppressive Drugs
Subjects (N=approximately 588) Enrolled 3 Yrs Post-Transplant * Subjects with evidence of EBV infection prior to transplant * Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
Procedure: transplant · Drug: Immunosuppressive Drugs
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).
Also known as: transplantation
Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.
Also known as: Immunosuppressive Medications
Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD)
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)
Time frame: Receipt of transplanted organ(s) to confirmation of EBV-positive PTLD, up to year 4 post - enrollment
Specified Gain-of-Function Mutations in EBV Latent Membrane Protein 1 (LMP-1)
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
Time frame: Receipt of transplanted organ(s) to confirmation of mutations in EBV LMP1 , up to year 4 post - enrollment
Pathogenic Changes in B Cell Clonotype Development
Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)
Time frame: Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Lymphoproliferative Disorders→
National Institute of Allergy and Infectious Diseases (NIAID)