Genotyping of Cytomegalovirus From Patients in Israel
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Infections
Phase: N/A
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s): Naty Keller, MD/PhD, Study Director, Affiliation: Sheba Medical Center
Overall contact: Ella Mendelson, PhD, Phone: 972-3-530-2421, Email: ellamen@sheba.health.gov.il
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.
Clinical Details
Official title: Cytomegalovirus Glycoprotein B Genotypes in Israeli Patients: Relationship Between CMV Genotype, Clinical and Demographic Factors
Study design: Observational Model: Natural History, Time Perspective: Cross-Sectional
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ella Mendelson, PhD, Phone: 972-3-530-2421, Email: ellamen@sheba.health.gov.il
Central Virology Laboratory, Chaim Sheba Medical Center Tel-Hashomer, Ramat Gan 52621, Israel; Recruiting Ella Mendelson, PhD, Phone: 972-3-530-2421, Email: ellamen@sheba.health.gov.il Zehava Grossman, PhD, Phone: 972-3-530-2458, Email: zehava.grossman@sheba.health.gov.il Ella Mendelson, PhD, Principal Investigator Musa Hindiyeh, PhD, Sub-Investigator
Additional Information
Starting date: September 2005
Last updated: August 17, 2006
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