CompletedNot Applicable

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

United States944 participantsStarted 2014-08-14

Plain-language 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).

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD)

Timeframe: Receipt of transplanted organ(s) to confirmation of EBV-positive PTLD, up to year 4 post - enrollment

Specified Gain-of-Function Mutations in EBV Latent Membrane Protein 1 (LMP-1)

Timeframe: Receipt of transplanted organ(s) to confirmation of mutations in EBV LMP1 , up to year 4 post - enrollment

Pathogenic Changes in B Cell Clonotype Development

Timeframe: Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment

Trial details

NCT IDNCT02182986

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2019-05-15

View on ClinicalTrials.gov More Heart Transplant trials