Clinical trial · Observational
Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients
Monocentric Study on the Clinical and Ultrasound Incidence of Rheumathologic Immune Related Adverse Events in Patients Affected by Stage IIB, IIC, III and IV Melanoma Under Therapy With Immune-checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0 | Other | — | UNRESOLVED |
| Joint ultrasonography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients.
- timeFrame
- 3 years
- description
- Patients will undergo a rheumatologic visit and joint ultrasonography at baseline and at scheduled follow-ups in order to assess the incidence of rheumatologic immune related adverse events.
Secondary outcomes (3)
- measure
- Description of the main characteristics of the rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy.
- timeFrame
- 3 years
- description
- A rheumatologist will clinically and ultrasonographically characterize the main features of the rheumatologic immune related adverse events occuring during immunotherapy.
- measure
- Identification of baseline risk factors associated with occurrence of rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available