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

NCT ID: NCT06780397

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-02-01

Brief 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.

Conditions

Melanoma, Stage II; Melanoma Stage III; Melanoma Stage IV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ketty Peris, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia

Rome, Lazio, Italy

Countries

Italy

Central Contacts

Ketty Peris, Prof

Role: CONTACT

ketty.peris@policlinicogemelli.it

+390630154211

Facility Contacts

Ketty Peris, Prof

Role: primary

ketty.peris@policlinicogemelli.it

+390630154211

Maria Mannino, MD

Role: backup

mariamannino04@yahoo.it

Other Identifiers

6839

Identifier Type: -

Identifier Source: org_study_id