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CompletedNCT00641121Updated Jan 12, 2018

Bethaherpesviruses in Children Who Are Immune Suppressed

An observational study in Immune Suppressed Children, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2018-01-12.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
Up to 21 Years
Sex
All
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Study 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.

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Conditions studied

  • Immune Suppressed Children
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In context

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
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

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) -
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (actual)
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Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00641121
Lead sponsor
The Cleveland Clinic
Responsible party
Johanna Goldfarb (Contract Staff, The Cleveland Clinic) — Principal investigator
First posted
Mar 21, 2008
Start date
Nov 2005
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Jan 12, 2018

Study contacts

Johanna Goldfarb, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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