Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children
1 other identifier
observational
944
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedStudy Start
First participant enrolled
August 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedAugust 29, 2019
August 1, 2019
4.8 years
June 30, 2014
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD)
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)
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)
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
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
Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)
Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment
Study Arms (2)
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
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
Interventions
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 prescribed as standard of care to prevent rejection of the allograft.
Eligibility Criteria
Pediatric Candidates for or recipients of heart, liver, heart with liver, kidney, small intestine, or liver with small intestine at participating major pediatric solid organ transplant programs
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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California, Los Angeles
Los Angeles, California, 90095, United States
Lucile Packard Children's Hospital Stanford
Stanford, California, 94305, United States
Medstar Georgetown Transplant Institute
Washington D.C., District of Columbia, 20057, United States
University of Miami Health System
Miami, Florida, 33101, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
University of Texas Southwestern
Dallas, Texas, 75235, United States
Related Publications (1)
Rao M, Amouzgar M, Harden JT, Lapasaran MG, Trickey A, Armstrong B, Odim J, Debnam T, Esquivel CO, Bendall SC, Martinez OM, Krams SM. High-dimensional profiling of pediatric immune responses to solid organ transplantation. Cell Rep Med. 2023 Aug 15;4(8):101147. doi: 10.1016/j.xcrm.2023.101147. Epub 2023 Aug 7.
PMID: 37552988DERIVED
Related Links
Biospecimen
Blood and tissue samples.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Esquivel, M.D., Ph.D.
Stanford University
- STUDY CHAIR
Daniel Bernstein, M.D.
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 8, 2014
Study Start
August 14, 2014
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
August 29, 2019
Record last verified: 2019-08