Diagnostic and Prognostic Validity of Tissue-based Biomarker Assay for Acute Graft-versus-host Disease of the Skin: A Retrospective Study

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
    • Scottsdale/Phoenix, Arizona: 17-004717
    • Jacksonville, Florida: 17-004717
    • Rochester, Minnesota: 17-004717
    Sponsor Protocol Number: 17-004717

About this study

The purpose of this study is to validate the diagnostic and prognostic utility of our tissue-based assay, the aim is to perform a multi-institution, retrospective study of our assay compared with the current clinical gold standard (clinicopathologic correlation and prospective observation of clinical course, respectively). 

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:

  • Adults who have undergone hematopoietic cell transplantation, with skin biopsies showing acute graft-versus-host disease (GVHD) or non-GVHD mimicking rash  
  • Patients with specimens with sufficient tissue remaining in the tissue block 
  • Patients for whom ≥3 months follow-up information (or date of expiration, if within 3 months of biopsy) is available in the medical record

Exclusion Criteria: 

  • Patients who decline to be involved in retrospective research 
  • Lack of inclusion criteria

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Julia Lehman, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Aaron Mangold M.D.

(480)301-5686

Mangold.Aaron@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Julia Lehman, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Mark Cappel M.D.

(904)953-7214

Cappel.Mark@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Julia Lehman, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Julia Lehman M.D.

(507)284-2555

Lehman.Julia@mayo.edu

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CLS-20358462

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