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Relationship Between EBV and PTLD

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ClinicalTrials.gov Identifier: NCT00215033
Recruitment Status : Terminated (sufficient data gathered to support conclusion)
First Posted : September 22, 2005
Last Update Posted : March 16, 2012
Sponsor:
Information provided by:
Children's Healthcare of Atlanta

Tracking Information
First Submitted Date September 20, 2005
First Posted Date September 22, 2005
Last Update Posted Date March 16, 2012
Study Start Date April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00215033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between EBV and PTLD
Official Title Relationship Between Quantitative Epstein-Bar Viral(EBV) Titres and Post-Transplant Lymphoproliferative Disease
Brief Summary 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.
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.
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergone pediatric heart transplant
Condition Pediatric Heart Transplant
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September¬†20,¬†2005)
160
Original Enrollment Same as current
Actual Study Completion Date May 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00215033
Other Study ID Numbers 05-089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Children's Healthcare of Atlanta
Collaborators Not Provided
Investigators
Principal Investigator: Brian Kogon, MD Emory University
PRS Account Children's Healthcare of Atlanta
Verification Date May 2007