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Relationship Between EBV and PTLD

This study has been terminated.
(sufficient data gathered to support conclusion)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215033
First Posted: September 22, 2005
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Healthcare of Atlanta
  Purpose
The purpose of this study is to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD.

Condition
Pediatric Heart Transplant

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Relationship Between Quantitative Epstein-Bar Viral(EBV) Titres and Post-Transplant Lymphoproliferative Disease

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 160
Study Start Date: April 2005
Study Completion Date: May 2006
Detailed Description:
The relationship between Epstein-Barr virus and lymphoproliferative disease has been established, particularly in the immuno-suppressed patient. Over the past several years a quantitative EBV PCR lab test has been established. Unfortunately, the significance of an elevated test remains unclear. The relationship of a particular EBV PCR value and the risk of developing PTLD is unknown. The primary aims will be to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD. The study will be conducted through a retrospective chart review of approximately 160 patients and we will look at postoperative data including Quantitative EBV PCR results, the presence / absence of PTLD and the treatment of PTLD and results of EBV PCR with treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergone pediatric heart transplant
Criteria

Inclusion Criteria:

  • patients undergone pediatric heart transplant
  • followed by pediatric heart transplant program

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215033


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Brian Kogon, MD Emory University
  More Information

ClinicalTrials.gov Identifier: NCT00215033     History of Changes
Other Study ID Numbers: 05-089
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: March 16, 2012
Last Verified: May 2007

Keywords provided by Children's Healthcare of Atlanta:
Epstein-Barr virus
pediatric health
cardiac
heart transplant
lymphoproliferative disease
post-transplant
pediatric transplant

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases