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NCT Number: NCT06780397

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

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.

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Key information

Conditions

Melanoma, Stage II Melanoma Melanoma Stage III Melanoma Stage IV Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia

Rome, Lazio, 00168, Italy

Location contact

Alessandro Di Stefani

SUB_INVESTIGATOR

Ketty Peris

PRINCIPAL_INVESTIGATOR

Ketty Peris, Prof

CONTACT

[email protected]

+390630154211

Laura Quattrini

SUB_INVESTIGATOR

Maria Mannino

SUB_INVESTIGATOR

Maria Mannino, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Joint ultrasonography

Diagnostic Test

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.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0

Other

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 outcomes

  1. 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

    Patients will undergo a rheumatologic visit and joint ultrasonography at baseline and at scheduled follow-ups in order to assess the incidence of rheumatologic immune related adverse events.

Secondary outcomes

  1. 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

    A rheumatologist will clinically and ultrasonographically characterize the main features of the rheumatologic immune related adverse events occuring during immunotherapy.

  2. 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

    Baseline clinical, dermatological, rheumatologic and ultrasonographic factors will be recorded and associated with the occurrence of rheumatologic immune related adverse events during immunotherapy.

  3. Evaluation of rheumatologic adverse events impact on patients' quality of life.

    Time frame: 3 years

    Patients will receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) at baseline and at scheduled timepoints, in order to investigate the impact of the occurrence of rheumatologic adverse events on patients' quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Ketty Peris, Prof

CONTACT

[email protected]

+390630154211

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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

Acronym: Mel-Immuno-Reu

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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