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Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study


N/A
N/A
N/A
Open (Enrolling)
Both
Epstein-Barr Virus Infections

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Trial Information

Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study


PTLD represents a heterogeneous group of abnormal lymphoid proliferations, generally of
B-cells, that occur in the setting of ineffective T-cell function because of pharmacological
immunosuppression. Because the vast majority of PTLDs are associated with Epstein-Barr virus
(EBV) infection, surveillance of EBV infection may have the potential to prevent the
development of PTLD by early intervention. However, the cut-off values of "high" EBV viral
load remain badly defined due to a lack of prospective studies and assay standardization.
The aim of this ongoing multicenter prospective study is the serial detection of primary EBV
infection or reactivation in a homogeneous patient population of pediatric renal transplant
recipients during the first 2 years posttransplant by the combined analysis of quantitative
EBV viral load by a standardized quantitative PCR technique, EBV serology and EBV-specific
T-lymphocytes for the identification of high-risk patients.


Inclusion Criteria:



- male and female pediatric and adult renal transplant recipients with written informed
consent

Exclusion Criteria:

- psychological illness which does not allow patient to understand the study and
participate following his own free will

- no written informed consent

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

EB viral load, serology and EBV-specific T cell in pediatric (and adult) renal transplant recipients with or without clinical symptoms of EBV, PTLD etc.

Outcome Time Frame:

9 years

Safety Issue:

No

Principal Investigator

Burkhard Toenshoff, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Children's Hospital of Heidelberg

Authority:

Germany: Ethics Commission

Study ID:

BToenshoff002

NCT ID:

NCT00963248

Start Date:

July 2003

Completion Date:

August 2010

Related Keywords:

  • Epstein-Barr Virus Infections
  • EBV
  • PTLD
  • RTx
  • pediatric
  • Virus Diseases
  • Epstein-Barr Virus Infections

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