Genotyping of Cytomegalovirus From Patients in Israel

August 17, 2006 updated by: Sheba Medical Center

Cytomegalovirus Glycoprotein B Genotypes in Israeli Patients: Relationship Between CMV Genotype, Clinical and Demographic Factors

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Central Virology Laboratory, Chaim Sheba Medical Center Tel-Hashomer
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ella Mendelson, PhD
        • Sub-Investigator:
          • Musa Hindiyeh, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Director: Naty Keller, MD/PhD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (ESTIMATE)

September 28, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 17, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-05-3867-NK-CTIL
  • Sara Orzi MSc thesis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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