Cytomegalovirus InfectionsNCT00228202
Genotyping of Cytomegalovirus From Patients in Israel
An observational study of Cytomegalovirus Infections, run by Sheba Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Central Virology Laboratory, Chaim Sheba Medical Center Tel-Hashomer
Ramat Gan, 52621
Ella Mendelson, PhD, 972-3-530-2421, ellamen@sheba.health.gov.il
Zehava Grossman, PhD, 972-3-530-2458, zehava.grossman@sheba.health.gov.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Cytomegalovirus Infections
- Keywords
- cytomegalovirus, CMV, pregnancy, amniotic fluid, bone marrow, transplantation, viral load, glycoprotein B, genotyping, PCR, real-time PCR, CMV disease, Congenital CMV infection
- Medical subject headings
- Cytomegalovirus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Naty Keller, MD/PhD, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228202
- Sponsor's protocol ID
- SHEBA-05-3867-NK-CTIL
- Other IDs
- Sara Orzi MSc thesis
- Status last verified
- Jan 2006
- First submitted
- 26 Sep 2005
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus Glycoprotein B Genotypes in Israeli Patients: Relationship Between CMV Genotype, Clinical and Demographic Factors
- ClinicalTrials.gov ID
- NCT00228202
- Acronym / sponsor ID
- SHEBA-05-3867-NK-CTIL
- Conditions
- Cytomegalovirus Infections
- Keywords
- cytomegalovirus, CMV, pregnancy, amniotic fluid, bone marrow, transplantation, viral load, glycoprotein B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2005
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naty Keller, MD/PhD study director
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ella Mendelson, PhD (972-3-530-2421, ellamen@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.