A Study to Evaluate Clinical Performance of the Aptima® CMV Quant Assay on the Panther® System

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymund Razonable, M.D.

Open for enrollment

Contact information:

Julie Gecox Hanson CCRP

(507)293-6592

Gecox.Julie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20458952

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