A Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients.

May 20, 2011 updated by: Mayo Clinic

Kinetics of Cytomegalovirus (CMV) Replication and CMV-specific Immune Reconstitution After Hematopoietic Stem Cell Transplantation.

This study is being done to determine how the body fights off a common virus known as Cytomegalovirus (CMV). CMV is a virus that commonly infects humans and causes disease in patients with compromised immune function such as those who receive organ and tissue transplant. By knowing how the human body responds to the infection, researchers will be able to develop better methods on how to prevent this infection.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is looking at the CMV virus in Hematopoietic stem cell donors and recipients. In the donor population, the study is looking at the participants blood to see if they contain cells that are active against the virus. Information about the donor will be obtained through an interview and through review of medical records. A blood sample will be drawn at the time of the donor's evaluation, which will take place in conjunction with the regular blood tests that are ordered. Participants of the study who are donors will only be involved in the study at the time of blood collection.

Participants who will be receiving hematopoietic stem cell transplantation will have data collected through an interview and review of medical records. Participants will have blood drawn prior to transplant, weekly for 12 weeks and then monthly for three months following transplant. In addition, if CMV disease develops during this period of time, blood will be drawn till the participant is cured for the disease. All blood draws for thes study will take place in conjunction with the regular routine blood work. Participants will be in the study for one year after transplant.

Study Type

Observational

Enrollment

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

rticipants who will be undergoing blood marrow or stem cell transplant and donors that are 18 years of age or older, may be eligible to participate in this study.

Description

Participants who will be undergoing blood marrow or stem cell transplant and donors that are 18 years of age or older, may be eligible to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To characterize the kinetics of CMV-specific immunity after HSCT.
To characterize the kinetics of CMV replication after HSCT.
To assess the degree of Epstein-Barr virus (EBV), human herpesvirus (HHV)-6 and HHV-7 replication after HSCT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Raymund R. Razonable, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 6, 2006

First Submitted That Met QC Criteria

January 6, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 24, 2011

Last Update Submitted That Met QC Criteria

May 20, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1052-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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