NCT02182986

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 944 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Heart Transplant
• Small Intestine Transplant
• Kidney Transplant
• Liver Transplant
• EBV-Related PTLD
• PTLDs

Interventions

Type	Name	Description
PROCEDURE	transplant	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).
DRUG	Immunosuppressive Drugs	Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.

Timeline

• Start date: 2014-08-14
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2014-07-08
• Last updated: 2019-08-29

Locations

7 sites across 1 country: United States