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Relationship Between EBV and PTLD

This study has been terminated.
(sufficient data gathered to support conclusion)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00215033
First received: September 20, 2005
Last updated: March 14, 2012
Last verified: May 2007
  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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00215033     History of Changes
Other Study ID Numbers: 05-089
Study First Received: September 20, 2005
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014