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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joint ultrasonography | Diagnostic Test | Patients will undergo rheumatologic visits at baseline and scheduled follow-ups. Rheumatologic visit procedures:
| ||
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0 | Other | Patients will undergo dermatologic visits at baseline and scheduled follow-ups. Dermatologic visit procedures:
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients. | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the main characteristics of the rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy. | A rheumatologist will clinically and ultrasonographically characterize the main features of the rheumatologic immune related adverse events occuring during immunotherapy. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients affected by stage IIB-IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ketty Peris, Prof | Contact | +390630154211 | ketty.peris@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Ketty Peris, Prof | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia | Rome | Lazio | 00168 | Italy |
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| 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. | Baseline clinical, dermatological, rheumatologic and ultrasonographic factors will be recorded and associated with the occurrence of rheumatologic immune related adverse events during immunotherapy. | 3 years |
| Evaluation of rheumatologic adverse events impact on patients' quality of life. | Patients will receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) at baseline and at scheduled timepoints, in order to investigate the impact of the occurrence of rheumatologic adverse events on patients' quality of life. | 3 years |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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