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
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: 17-008736
Sponsor Protocol Number: 17-008736
About this study
The purpose of this study is to:
- Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
- Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
- 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. 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:
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Uma Thanarajasingam, M.D., Ph.D. |
Closed-enrolling by invitation |
|
More information
Publications
Publications are currently not available