A Study to Evaluate Clinical Performance of the Aptima® CMV Quant Assay on the Panther® System
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: 19-001676
Sponsor Protocol Number: 19-001676
About this study
The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).
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:
- Subject and/or legally authorized representative is willing and able to provide consent prior to study participation.
- Subject is ≥ 18 years of age.
- Subject is undergoing or a candidate for routine SOC monitoring per the collection sites’ CMV management protocol.
- Subject meets one of the following two criteria:
- Subject is a kidney, liver, lung, or heart transplant recipient; or
- Subject is an allogeneic or autologous HSCTR.
- Subject is serotype D+/R-, D-/R+ or D+/R+.
- Subject has a positive CMV result of equal to or above the LLOQ (≥LLOQ) within 10 days prior to enrollment with no intervening negative CMV result below the LLOQ (
Exclusion Criteria:
- Subject already participated in this study.
- Subject is unsuitable for study participation based on the PI’s decision (e.g., unlikely to comply with study procedure(s), significant medical complication).
- Subject is participating in another investigational study that the PI believes might interfere with the subject’s participation in this study.
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