Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

944 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-14

Study Completion Date

2019-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant

NCT00063648

Liver Disease Lymphoproliferative Disorders

COMPLETED PHASE1

Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant

NCT03131934

Post-transplant Lymphoproliferative Disease Transplant-Related Hematologic Malignancy

ACTIVE_NOT_RECRUITING EARLY_PHASE1

EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients

NCT00963248

Epstein-Barr Virus Infections

COMPLETED

Rituximab for Pediatric Renal Transplant Rejection

NCT00697996

Kidney Transplantation

COMPLETED PHASE2/PHASE3

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients

NCT05550298

Hematopoietic Cell Transplant Solid Organ Transplant Respiratory Viral Infection

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects Enrolled Pre-Transplant

Subjects (N=approximately 357) Enrolled Pre-Transplant

* Subjects with evidence of EBV infection prior to transplant
* Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant

transplant

Intervention Type 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).

Immunosuppressive Drugs

Intervention Type DRUG

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

Subjects Enrolled Post-Transplant

Subjects (N=approximately 588) Enrolled 3 Yrs Post-Transplant

* Subjects with evidence of EBV infection prior to transplant
* Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant

transplant

Intervention Type 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).

Immunosuppressive Drugs

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transplant

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).

Intervention Type PROCEDURE

Immunosuppressive Drugs

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

transplantation Immunosuppressive Medications

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.

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;

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No