Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

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.

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.