Skip to main content
OpenTrials
Completed

NCT Number: NCT02182986

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Transplant EBV-Related PTLD Kidney Transplant Liver Transplant PTLDs Small Intestine Transplant

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transplant

Procedure

All subjects enrolled in this study are candidates for/recipients of solid organ transplants as a therapeutic for end stage diseases (e.g., heart, liver, heart with liver, kidney, small intestine, or liver with small intestine transplants).

Other names: transplantation

Immunosuppressive Drugs

Drug

Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.

Other names: Immunosuppressive Medications

Primary outcomes

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

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

    The development of EBV positive PTLD during the study period as assessed by the local site pathologist, with confirmation of the PTLD diagnosis by the Study Clinicopathological Review Board (SCPRB)

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

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

    Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method

  3. Pathogenic Changes in B Cell Clonotype Development

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

    Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Trials in Organ Transplantation in Children

Registry information

Official study title

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children (CTOTC-06)

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2014
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.