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Набор скоро начнётся NCT07437300

Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.

— Наблюдательное Melanoma

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Melanoma. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The underlying hypothesis of the study is that melanoma patients treated with immunotherapy, whether in an adjuvant or curative setting, who consume more fiber would respond better to immunotherapy: either no recurrence in the case of adjuvant treatments, or no progression (disease stability, partial or complete response) in the case of curative treatments. The primary objective is to evaluate the association between total dietary fiber intake quantified using the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting

Первичные конечные точки

  • Association between total dietary fiber intake based on the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
Вторичные конечные точки (10)
  • association between a high-fiber diet and the occurrence of immunotoxicity [Срок оценки: during 6 months of immunotherapy initiation]
  • association between muscle surface index on L3 CT scan using ODIASP software (Automated Computerized Muscle Surface Determination Tool at the Psoas Level) and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • association between the presence of malnutrition at the start of treatment and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • association between high physical activity (GPAQ (Global Physical Activity Questionnaire) score) and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • association between uncontrolled diabetes (HbA1c > 7%) and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • association between antibiotic use in the 3 months prior to the start of treatment and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • association between prebiotic or probiotic use and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • ssociation between alcohol consumption and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • association between tobacco consumption and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • Association between the presence of a pet in the patient's home and response to immunotherapy [Срок оценки: follow-up imaging at 3 and 6 months in curative and adjuvant settings]

Критерии участия

Критерии включения

  • Melanoma treated with curative immunotherapy (IPILIMUMAB + NIVOLUMAB or NIVOLUMAB or PEMBROLIZUMAB or NIVOLUMAB + RELATLIMAB) or adjuvant immunotherapy (NIVOLUMAB or PEMBROLIZUMAB)
  • Patients monitored and treated at the dermatology day hospital at Grenoble Alpes University Hospital
  • Obtaining the patient's consent
  • Start of immunotherapy less than or equal to 1 year at the time of inclusion
  • Subject affiliated with social security system

Критерии исключения

  • Recurrence of the disease within 6 months or less after a first line of adjuvant treatment with immunotherapy for 1 year
  • Immunotherapy as a third line of treatment in metastatic situations
  • Squamous cell carcinoma or basal cell carcinoma treated with immunotherapy
  • Inability to complete the FiberTAG and GPAQ questionnaires (advanced neurocognitive disorders, memory loss, etc.)
  • Inclusion in an interventional clinical study
  • Immunotherapy in a neoadjuvant situation
  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care institution for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent). persons subject to legal protection measures)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07437300 · 38RC25.0434 · ID-RCB number

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗