Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06780397
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ketty Peris, Prof
Principal Investigator Affiliation	Fondazione Policlinico Universitario A. Gemelli, IRCCS
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Stage II, Melanoma Stage III, Melanoma Stage IV

Contact a Trial Team

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International Sites

Roma, Lazio, Italy

Status

Address

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia

Roma, Lazio, 00168

Site Contact

Ketty Peris, Prof

[email protected]

+390630154211

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