Overview

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

Status:
Completed
Trial end date:
2019-05-15
Target enrollment:
0
Participant gender:
All
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).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Clinical Trials in Organ Transplantation in Children
Treatments:
Immunosuppressive Agents
Criteria
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.