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Набор скоро начнётся NCT06780397

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

— Наблюдательное Melanoma, Stage II Melanoma Stage III Melanoma Stage IV

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Joint ultrasonography, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0.
Кому может быть актуально
Состояния в реестре: Melanoma, Stage II, Melanoma Stage III, Melanoma Stage IV. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Диагностический тест 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.
  • Другое 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.

Первичные конечные точки

  • Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients. [Срок оценки: 3 years]
Вторичные конечные точки (3)
  • Description of the main characteristics of the rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy. [Срок оценки: 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. [Срок оценки: 3 years]
  • Evaluation of rheumatologic adverse events impact on patients' quality of life. [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia — Rome

Идентификаторы

NCT: NCT06780397 · 6839

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗