A Study of the Quantiferon CMV Blood Test to Predict the Risk of CMV Returning After Treatment of the Disease in Solid Organ Transplant Recipients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003965
Sponsor Protocol Number: 14-003965
About this study
The overall aim of this study is to determine whether solid organ transplant recipients who develop immunity to cytomegalovirus (CMV) after an initial episode of CMV disease as measured by the QuantiFERON-CMV assay are at lower risk of CMV recurrence in the future.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients older than 18 years old, with solid organ transplant (kidney, heart, lung, pancreas or liver).
- Patients that have been identified of having CMV disease (syndrome or tissue invasive disease) by the above definitions.
- Patients that will require induction antiviral therapy (with ganciclovir, cidofovir, foscarnet or valganciclovir at induction doses) until 2 weekly CMV viral quantification tests by PCR are negative and who will be transitioned to secondary antiviral prophylaxis.
- Patients that provide informed consent to obtain blood samples for QuantiFERON-CMV testing at the above mentioned time points.
Exclusion Criteria:
- Documented episodes of CMV disease prior to the one at the time of inclusion to the study.
- Patients with asymptomatic CMV infection (that did not require the use of induction antiviral therapy).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Raymund Razonable, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available