Checks joint side effects in melanoma patients receiving immunotherapy
Looks for joint side effects in adults with melanoma receiving immune-checkpoint inhibitor treatment.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Rome, ItalySee the site
- Trial code
- Registry title
- Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 1 Feb 2025
- Expected to end
- 1 Feb 2028
- Type of study
- Observational
- Treatments tested
- Joint ultrasonography
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0
- Record updated
- 17 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IIB, IIC, III or IV melanoma who are starting immune-checkpoint inhibitor therapy. It studies joint and rheumatic side effects.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Melanoma stage IIB, IIC, III or IV.
- Earlier treatment
- Must be starting systemic therapy with immune-checkpoint inhibitors. No earlier immune-checkpoint inhibitor treatment, including earlier adjuvant therapy with them.
Main reasons for not taking part
- Under 18 years of age
- Unable to give consent to the study
- Chronic joint disease such as inflammatory arthritis, arthrosis, microcrystalline arthritis or septic arthritis
- Systemic disease that likely affects the joints, such as inflammatory bowel disease
- Earlier treatment with immune-checkpoint inhibitors
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors
- 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.)
- Patients aged below 18 years of age
- Patients who are unable to express consent to the study
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC DermatologiaRome, ItalyContact: Ketty Peris, ProfNo longer taking part
About the trial
What the trial wants to find out
Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.
Read full original descriptionShow less
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.
Treatments tested
- Joint ultrasonography
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Checks joint side effects in melanoma patients receiving immunotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 January 2025