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
  Purpose

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
Immune Suppressed Children

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bethaherpesviruses in Children Who Are Immune Suppressed

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Estimated Enrollment: 60
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chilren that are Immune suppressed

Criteria

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) -
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641121

Contacts
Contact: Johanna Goldfarb, MD 216-444-2200
Contact: Donna Londrico, RN 216-444-9620

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna Londrico, RN    216-444-9620      
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Johanna Goldfarb, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Johanna Goldfarb MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00641121     History of Changes
Other Study ID Numbers: 7689
Study First Received: March 18, 2008
Last Updated: March 20, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014