Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients (Mel-Immuno-Reu)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Melanoma Stage IV; Melanoma Stage III; Melanoma, Stage II

Treatments: Diagnostic Test: Joint ultrasonography; Other: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0

Study type: Observational

Funder types: Other

Identifiers

NCT06780397

6839

Details and patient eligibility

About

Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.

The main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.

Patients will:

• receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.
• undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
• undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
• receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.