Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how often certain joint and muscle problems, known as rheumatologic immune-related adverse events, occur in patients with advanced melanoma (a type of skin cancer) who are receiving a specific treatment called immune-checkpoint inhibitors. These issues are expected to happen in about 3% to 7.5% of patients but might not always be recognized. By using both physical exams and ultrasound imaging, the study aims to better understand how common these problems are in patients with stage IIB, IIC, III, and IV melanoma.

To participate in this trial, you must be an adult with one of the specified stages of melanoma and starting treatment with immune-checkpoint inhibitors. You will have routine visits with both skin and joint specialists before starting treatment and during follow-ups to monitor your health. Additionally, you will fill out a quality of life questionnaire to help the researchers understand how your treatment affects your daily life. Please note that individuals under 18, those who cannot provide consent, or those with certain existing joint conditions are not eligible to participate. This study aims to improve the recognition and management of potential side effects related to your treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
• • Signature of the patient consent to the study.
• Exclusion Criteria:
• • Patients aged below 18 years of age.
• • Patients who are unable to express consent to the study.
• • Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.
• • Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)
• • Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.