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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation in Children | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Enrolled Pre-Transplant | Subjects (N=approximately 357) Enrolled Pre-Transplant
|
| |
| Subjects Enrolled Post-Transplant | Subjects (N=approximately 588) Enrolled 3 Yrs Post-Transplant
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transplant | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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) | Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Esquivel, M.D., Ph.D. | Stanford University | Principal Investigator |
| Daniel Bernstein, M.D. | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Lucile Packard Children's Hospital Stanford |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38682750 | Derived | Tajima T, Martinez OM, Bernstein D, Boyd SD, Gratzinger D, Lum G, Sasaki K, Tan B, Twist CJ, Weinberg K, Armstrong B, Desai DM, Mazariegos GV, Chin C, Fishbein TM, Tekin A, Venick RS, Krams SM, Esquivel CO. Epstein-Barr virus-associated post-transplant lymphoproliferative disorders in pediatric transplantation: A prospective multicenter study in the United States. Pediatr Transplant. 2024 Jun;28(4):e14763. doi: 10.1111/petr.14763. | |
| 37552988 |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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Blood and tissue samples.
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| Immunosuppressive Drugs | Drug | Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft. |
|
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| Stanford |
| California |
| 94305 |
| United States |
| Medstar Georgetown Transplant Institute | Washington D.C. | District of Columbia | 20057 | United States |
| University of Miami Health System | Miami | Florida | 33101 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Texas Southwestern | Dallas | Texas | 75235 | United States |
| Derived |
| Rao M, Amouzgar M, Harden JT, Lapasaran MG, Trickey A, Armstrong B, Odim J, Debnam T, Esquivel CO, Bendall SC, Martinez OM, Krams SM. High-dimensional profiling of pediatric immune responses to solid organ transplantation. Cell Rep Med. 2023 Aug 15;4(8):101147. doi: 10.1016/j.xcrm.2023.101147. Epub 2023 Aug 7. |
| Clinical Trials in Organ Transplantation in Children (CTOT-C) | View source |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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