Cytomegalovirus (CMV) MicroRNA Expression in Vivo and Immune Evasion Correlates

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Deepali Kumar, University of Alberta

ClinicalTrials.gov Identifier:

NCT00677482

First received: May 12, 2008

Last updated: April 20, 2012

Last verified: April 2012

History of Changes

Purpose

Cytomegalovirus (CMV) is the most common viral infection in patients who have undergone a transplant.Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. The purpose of this study is to assess how the virus interacts with the patient's immune system, so that in the future it may be possible to develop better ways to prevent and treat the virus infection.

Condition
Transplant

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Cytomegalovirus (CMV) microRNA Expression in Vivo and Immune Evasion Correlates

Further study details as provided by University of Alberta:

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Solid organ transplant recipients with both asymptomatic CMV viremia, and symptomatic CMV disease are eligible for inclusion in the study. THis includes liver, kidney, heart, pancreas, lung, intestinal and combined transplant recipients.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Solid organ tranplant recipients with both asymptomatic CMV viremia and symptomatic CMV disease are eligible for inclusion in the study. This include liver, kidney, heart, pancreas, lung, intestinal and combined transplant recipients.

Criteria

Inclusion Criteria:

Male or female patients who fulfill the following criteria are eligible for inclusion:

Age >=18 years
Solid Organ Transplant Recipients
Documented CMV disease or asymptomatic CMV viremia

Exclusion Criteria:

Unable to comply with protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677482

Locations

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2E1

Sponsors and Collaborators

University of Alberta

Investigators

Principal Investigator:

Atul Humar, MD

University of Alberta

More Information

Publications:

Gandhi MK, Khanna R. Human cytomegalovirus: clinical aspects, immune regulation, and emerging treatments. Lancet Infect Dis. 2004 Dec;4(12):725-38. Review.

Preiksaitis JK, Brennan DC, Fishman J, Allen U. Canadian society of transplantation consensus workshop on cytomegalovirus management in solid organ transplantation final report. Am J Transplant. 2005 Feb;5(2):218-27. Review. Erratum in: Am J Transplant. 2005 Mar;5(3):635.

Humar A, Kumar D, Boivin G, Caliendo AM. Cytomegalovirus (CMV) virus load kinetics to predict recurrent disease in solid-organ transplant patients with CMV disease. J Infect Dis. 2002 Sep 15;186(6):829-33. Epub 2002 Aug 28.

Rasmussen L. Molecular pathogenesis of human cytomegalovirus infection. Transpl Infect Dis. 1999 Jun;1(2):127-34. Review.

Tomasec P, Wang EC, Davison AJ, Vojtesek B, Armstrong M, Griffin C, McSharry BP, Morris RJ, Llewellyn-Lacey S, Rickards C, Nomoto A, Sinzger C, Wilkinson GW. Downregulation of natural killer cell-activating ligand CD155 by human cytomegalovirus UL141. Nat Immunol. 2005 Feb;6(2):181-8. Epub 2005 Jan 9.

Responsible Party:	Deepali Kumar, Assistant Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier:	NCT00677482 History of Changes
Other Study ID Numbers:	7304
Study First Received:	May 12, 2008
Last Updated:	April 20, 2012
Health Authority:	Canada: Health Canada

Keywords provided by University of Alberta:

liver transplant
lung transplant
kidney transplant
heart transplant
CMV microRNA

ClinicalTrials.gov processed this record on May 16, 2013

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