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Genotyping of Cytomegalovirus From Patients in Israel

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: NCT00228202
Recruitment Status : Unknown
Verified January 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : September 28, 2005
Last Update Posted : August 18, 2006
Information provided by:
Sheba Medical Center

Brief Summary:
The researchers select 100 cytomegalovirus (CMV) DNA samples from patients diagnosed with CMV infection. Patients include bone marrow transplant patients, pregnant women and newborns. The researchers determine viral load by real-time polymerase chain reaction (PCR). They amplify CMV-gB sequences by PCR and type by sequencing and restriction fragment length polymorphism (RFLP). The researchers obtain clinical data from patients' records. They examine association between patients' clinical status and CMV-gB genotype and viral load.

Condition or disease
Cytomegalovirus Infections

Detailed Description:

The study aims at finding association between CMV viral load and viral glycoprotein B genotype and the clinical status of patients suffering from CMV infection. Bone marrow transplant patients are at increased risk of developing severe CMV disease and are routinely followed for viral load. Fetuses are also at high risk for developing severe malformations and neurological defects following maternal primary infection during pregnancy. Therefore amniotic fluid from women diagnosed with CMV infection is examined for CMV presence. Newborns having congenital defects are tested for CMV excretion.

There is not yet any confirmed marker for assessment of the potential severity of the viral infection and for prognosis. Therefore we shall attempt to find association between the viral load and genotype and the clinical status.

CMV DNA samples prepared at the Central Virology Laboratory from clinical specimens obtained from patients for diagnostic purposes will be coded and then subjected to viral load analysis using real-time PCR. The gB genotype will be determined by either of two methods described in the literature: (a) PCR and RFLP (b) PCR and sequencing.

Relevant clinical data will be retrieved from the patients clinical records and saved as coded information to match the samples. Bone marrow transplant patients will be followed for prolonged periods covering repeated viral reactivation events. Clinical records from mothers and newborns will be matched when present. Otherwise maternal and newborn samples will be kept as is.

Statistical analysis will be performed to try and find association between the clinical status of patients, the viral load and the viral genotype.

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Study Type : Observational
Enrollment : 100 participants
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Cytomegalovirus Glycoprotein B Genotypes in Israeli Patients: Relationship Between CMV Genotype, Clinical and Demographic Factors
Study Start Date : September 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CMV DNA sample from a transplant patient with CMV disease.
  • CMV DNA from amniotic fluid of women with CMV infection
  • CMV DNA from urine of newborns with congenital defects compatible with CMV.

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): NCT00228202

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Contact: Ella Mendelson, PhD 972-3-530-2421
Contact: Naty Keller, MD/PhD 972-3-530-2304

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Central Virology Laboratory, Chaim Sheba Medical Center Tel-Hashomer Recruiting
Ramat Gan, Israel, 52621
Contact: Ella Mendelson, PhD    972-3-530-2421   
Contact: Zehava Grossman, PhD    972-3-530-2458   
Principal Investigator: Ella Mendelson, PhD         
Sub-Investigator: Musa Hindiyeh, PhD         
Sponsors and Collaborators
Sheba Medical Center
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Study Director: Naty Keller, MD/PhD Sheba Medical Center

Layout table for additonal information Identifier: NCT00228202     History of Changes
Other Study ID Numbers: SHEBA-05-3867-NK-CTIL
Sara Orzi MSc thesis
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: January 2006
Keywords provided by Sheba Medical Center:
amniotic fluid
bone marrow
viral load
glycoprotein B
real-time PCR
CMV disease
Congenital CMV infection
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents