NCT00001976

Brief Summary

This study will evaluate the reliability of a new test called Real-Time Polymerase chain reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course of CMV disease in patients who have recently had a bone marrow transplant. The test's effectiveness will be compared with that of the "pp65 antigenemia assay" now routinely used for this purpose. CMV is a common virus that is transmitted from person to person by close personal contact. In most healthy people, CVM can remain in the body indefinitely without causing any harm. But, in people with weakened immune systems-including those who have just undergone bone marrow transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are available to treat this infection, however. Optimum treatment depends on early and accurate detection. Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase 1, patients will have blood drawn for both RT PCR and antigenemia testing once before the bone marrow transplantation and then weekly for the first 100 days after the transplant. During Phase 2-which begins immediately after the end of phase 1 and continues for one year after the transplant-blood samples for both tests will be drawn up to once a week. The samples for both tests will be collected at the same time and will be taken through a catheter (a thin flexible tube inserted into a vein) that has already been placed for the transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over the course of the 1-year study. It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV infection and predicting disease development, thus enabling doctors to plan early and effective treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2000

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2003

First QC Date

January 20, 2000

Last Update Submit

March 3, 2008

Conditions

Cytomegalovirus InfectionInfection

Keywords

CMVInfectionComparisonObservationalCytomegalovirusRT-PCR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Male or female patients that are 10 years of age or older up to 80 years of age are included. Patients must be enrolled in a protocol at the NIH Clinical Center that will result in the patient receiving an allogeneic stem cell transplant (A-HSCT). Patients who have not yet received a pre-transplant chemotherapy and radiation therapy conditioning regimen are eligible. Patients must not have a negative IgG serologic test for CMV and whose hematopoietic stem cell donor also has a negative IgG serologic test as reported by the Bone Marrow Transplant staff. Patients must not have documentation of prior cytomegalovirus antigenemia or disease prior to starting the conditioning regimen.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Sable CA, Donowitz GR. Infections in bone marrow transplant recipients. Clin Infect Dis. 1994 Mar;18(3):273-81; quiz 282-4. doi: 10.1093/clinids/18.3.273. No abstract available.

    PMID: 8011804BACKGROUND

  • Rowe JM, Ciobanu N, Ascensao J, Stadtmauer EA, Weiner RS, Schenkein DP, McGlave P, Lazarus HM. Recommended guidelines for the management of autologous and allogeneic bone marrow transplantation. A report from the Eastern Cooperative Oncology Group (ECOG). Ann Intern Med. 1994 Jan 15;120(2):143-58. doi: 10.7326/0003-4819-120-2-199401150-00008.

    PMID: 8256974BACKGROUND

  • Boeckh M, Gooley TA, Myerson D, Cunningham T, Schoch G, Bowden RA. Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment after allogeneic marrow transplantation: a randomized double-blind study. Blood. 1996 Nov 15;88(10):4063-71.

    PMID: 8916975BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus InfectionsInfections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 20, 2000

First Posted

January 21, 2000

Study Start

January 1, 2000

Study Completion

February 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-02

Locations

US(1)