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

NCT06780397 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-01-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

OTHER

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Ketty Peris, Prof · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2027-02-01
Completion
2028-02-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780397 on ClinicalTrials.gov