Menu
Not yet recruiting NCT06780397

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

— Observational Melanoma, Stage II Melanoma Stage III Melanoma Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Joint ultrasonography, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0.
Who it may be relevant to
Registry conditions: Melanoma, Stage II, Melanoma Stage III, Melanoma Stage IV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients. [Time frame: 3 years]
Secondary outcome measures (3)
  • Description of the main characteristics of the rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy. [Time frame: 3 years]
  • Identification of baseline risk factors associated with occurrence of rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy. [Time frame: 3 years]
  • Evaluation of rheumatologic adverse events impact on patients' quality of life. [Time frame: 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia — Rome

Identifiers

NCT: NCT06780397 · 6839

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗