Actively Recruiting

Age: 18Years +
All Genders
ID06647134

A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

Led by M.D. Anderson Cancer Center · Updated on 2026-04-13

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the experiences of people who develop rheumatic immune-related adverse events (irAEs) after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.

CONDITIONS

Brief Title

A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years and above
  • English-speaking with ability to give informed consent
  • Diagnosis by a rheumatologist of inflammatory arthritis or polymyalgia rheumatica as immune-related adverse events following immune checkpoint inhibitor therapy
Not Eligible

You will not qualify if you...

  • Acutely life-threatening or worsening cancer
  • Hearing impairment that limits participation in verbal interview

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual)

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo assessments to document the severity and impact of rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy.

Periodic interviews and assessments during the study period

Long-term Monitoring

Duration - Through study completion; an average of 1 year

Participants are observed for the ongoing safety and adverse events related to rheumatic immune-related adverse events throughout the study.

Follow-up interviews and assessments as scheduled

Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

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Research Team

Y

Y. Jeff Li, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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