Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00273143
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease
Cytomegalovirus Infection

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.


Layout table for study information
Study Type : Observational
Enrollment : 50 participants
Time Perspective: Prospective
Official Title: Kinetics of Cytomegalovirus (CMV) Replication and CMV-specific Immune Reconstitution After Hematopoietic Stem Cell Transplantation.
Study Start Date : May 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria
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.

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): NCT00273143


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Raymund R. Razonable, M.D. Mayo Clinic

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00273143     History of Changes
Other Study ID Numbers: 1052-05
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Layout table for MeSH terms
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases