Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-02-01
Completion Date
2028-02-01
Last Updated
2025-01-17
Healthy Volunteers
No
Interventions
Joint ultrasonography
Patients will undergo rheumatologic visits at baseline and scheduled follow-ups. Rheumatologic visit procedures: * collection of patients' anamnesis of rheumatologic diaseases. * identification of painful and/or swollen joints and enthesis. * evaluation of joint and enthesis pain. * joint ultrasonography and assessment of joint structures and enthesis.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0
Patients will undergo dermatologic visits at baseline and scheduled follow-ups. Dermatologic visit procedures: * collection of patients' oncologic anamnesis and general personal and lifestyle information. * administration of the quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) to assess the impact of rheumatologic adverse events on patients' quality of life.
Locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
Rome, Lazio, Italy