Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Kidney Transplant; Small Intestine Transplant; Liver Transplant; Heart Transplant; PTLDs; EBV-Related PTLD

Treatments: Drug: Immunosuppressive Drugs; Procedure: transplant

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02182986

DAIT CTOTC-06

Details and patient eligibility

About

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).

Full 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.

Enrollment: 944 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject and/or parent or legal guardian must be able to understand and provide informed consent/assent;
• Candidate for or recipient of: heart, liver, heart with liver, small intestine, liver with small intestine, or kidney; and
• Subject enrolled within 3 years of transplant.

Exclusion criteria

• Previous diagnosis of PTLD;
• Transplant recipients of lung alone, or in combination with an eligible organ type;
• Pancreas transplantation with the exception of 'en bloc' transplant in combined liver and small intestine multivisceral transplantation;
• Any combination other than listed in inclusion criteria;
• History of any previous solid organ, stem cell, or bone marrow transplantation;
• Inability or unwillingness of the legal guardian and/or the subject to comply with the study protocol.

Trial design

944 participants in 2 patient groups

Subjects Enrolled Pre-Transplant

Description:

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

Treatment:

Procedure: transplant

Drug: Immunosuppressive Drugs

Subjects Enrolled Post-Transplant

Description:

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

Treatment:

Procedure: transplant

Drug: Immunosuppressive Drugs