SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02182986

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children (CTOTC-06)

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).

NCT02182986 Heart Transplant Small Intestine Transplant Kidney Transplant Liver Transplant EBV-Related PTLD PTLDs
MeSH: Lymphoproliferative Disorders
HPO: Lymphoproliferative disorder

2 Interventions

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: Procedure

Subjects Enrolled Pre-Transplant Subjects Enrolled Post-Transplant

Name: Immunosuppressive Drugs

Description: Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.

Type: Drug

Subjects Enrolled Pre-Transplant Subjects Enrolled Post-Transplant


Primary Outcomes

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 - enrollment

Description: 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 - enrollment

Description: 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 - enrollment

Time Perspective: Prospective

Case-Control


There are 2 SNPs

SNPs


1 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 ---


2 S366T

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 ---



HPO Nodes


HPO:
Lymphoproliferative disorder
Genes 8
KRAS MYD88 IL2RG CD70 CD27 MCM4 NRAS ZAP70