A Study to Better Understand How to Predict and Manage Patients Who are at High Risk for Developing Rheumatic Immune-related Adverse Events While Receiving Treatment for Melanoma

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: 17-008736
    Sponsor Protocol Number: 17-008736

About this study

The purpose of this study is to:

  1. Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
  2. Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
  3. Establish a repository of biological samples from patients with irAE and corresponding rheumatologic

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:

From the Melanoma Clinic at Mayo Clinic, the aim is to recruit the following groups of melanoma patients receiving ICI therapy:

  • Patients without pre-existing rheumatologic disease, who have not developed any irAE at recruitment.
  • Patients with pre-existing rheumatologic disease, who have not developed any irAE at recruitment.
  • Patients without pre-existing rheumatologic disease who have developed any non-rheumatic irAE.
  • Patients without pre-existing rheumatologic disease who develop a de novo rheumatic irAE.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Uma Thanarajasingam, M.D., Ph.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:

Jane Jaquith C.C.R.C.

(507)284-4502

jaquith.jane@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions