Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

Completed

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

In brief

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).

Key facts

Study ID

NCT02182986

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

944

Starts

2014-08-14

Expected to finish

2019-05-15

Last updated by the study team

2019-08-29

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital Stanford — Stanford, California, United States
• Medstar Georgetown Transplant Institute — Washington D.C., District of Columbia, United States
• University of Miami Health System — Miami, Florida, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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