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Bethaherpesviruses in Children Who Are Immune Suppressed

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. Identifier: NCT00641121
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Johanna Goldfarb, The Cleveland Clinic

Brief Summary:

Unexplained fever in children with cancer is a common occurrence, often requiring hospital admission for evaluation and treatment with intravenous antibiotics. While empiric use of intravenous antibiotics is the norm in this population, between 48-70% of febrile and neutropenic episodes remain without an identifiable source. An understudied area is the potential role of betaherpesvirus infections in such febrile episodes. These viruses are significant pathogens in patients who become immunocompromised in conjunction with organ transplantation or acquired immune deficiency syndrome (AIDS). It is possible that they are similarly pathogenic in children who become immunocompromised due to cancer chemotherapy.

Thus, we will investigate the association between the betaherpesviruses and fever in children with cancer. The betaherpesviruses include cytomegalovirus (CMV), human herpesvirus 6A (HHV-6A), human herpesvirus 6B (HHV-6B), and human herpesvirus 7 (HHV-7). These viruses are grouped based on shared biological and genetic properties. Each is commonly acquired in childhood, persists in the human host, and can reactivate. Reactivation occurs intermittently throughout life in healthy individuals and is seldom associated with disease. Immune suppression is associated with a higher likelihood of reactivation and clinical disease. Latency of these viruses involves highly regulated processes that result in the viruses evading destruction and persisting within the host. Should balance be disrupted, as with cancer and anticancer therapy altering the normal host state, the environment may become favorable for betaherpesvirus reactivation, leading to disease and further alterations of the immune system.

Condition or disease
Immune Suppressed Children

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bethaherpesviruses in Children Who Are Immune Suppressed
Study Start Date : November 2005
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chilren that are Immune suppressed

Inclusion Criteria:

  1. Newly diagnosed with cancer (leukemia, lymphoma, or solid tumor)
  2. Undergoing solid organ pre-transplantation evaluation
  3. Age birth to 21 years

Exclusion Criteria:

  1. Unwilling to participate in the study
  2. Unwilling to have specimens stored for future research
  3. Clinical conditions preclude the required amount of blood to be drawn for the study
  4. Patient has malignancy that has relapsed
  5. Patient is not a primary transplant candidate (ie. has already had a solid organ transplant) -

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 identifier (NCT number): NCT00641121

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Johanna Goldfarb, MD The Cleveland Clinic
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Responsible Party: Johanna Goldfarb, Contract Staff, The Cleveland Clinic Identifier: NCT00641121    
Other Study ID Numbers: 7689
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018