Bethaherpesviruses in Children Who Are Immune Suppressed

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00641121
First received: March 18, 2008
Last updated: March 20, 2008
Last verified: March 2008

March 18, 2008
March 20, 2008
November 2005
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Complete list of historical versions of study NCT00641121 on ClinicalTrials.gov Archive Site
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Bethaherpesviruses in Children Who Are Immune Suppressed
Bethaherpesviruses in Children Who Are Immune Suppressed

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Chilren that are Immune suppressed

Immune Suppressed Children
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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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) -
Both
up to 11 Years
No
Contact: Johanna Goldfarb, MD 216-444-2200
Contact: Donna Londrico, RN 216-444-9620
United States
 
NCT00641121
7689
No
Johanna Goldfarb MD, Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Johanna Goldfarb, MD The Cleveland Clinic
The Cleveland Clinic
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP