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Идёт набор NCT05037825

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

— Наблюдательное Non-Small-Cell Lung Carcinoma Malignant Melanoma Renal Cell Carcinoma Triple-Negative Breast Cancer

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: Checkpoint Inhibitor, Immune.
Кому может быть актуально
Состояния в реестре: Non-Small-Cell Lung Carcinoma, Malignant Melanoma, Renal Cell Carcinoma, Triple-Negative Breast Cancer. 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
США
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 microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.

Вмешательства

  • Препарат Checkpoint Inhibitor, Immune
    anti-PD-1, anti-PD-L1, or anti-CTLA-4 as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent

Первичные конечные точки

  • Change in microbiome composition from baseline to after Cycle 2 of checkpoint therapy (6-8 weeks) by analyzing longitudinally-collected stool specimens of 800 patients with primary NSCLC, MM, RCC, and TNBC [Срок оценки: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 of checkpoint blockade immunotherapy (at approximately 6-8 weeks) ]]
Вторичные конечные точки (3)
  • Microbiome samples correlation [Срок оценки: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)]
  • Microbiome correlation to blood biomarkers [Срок оценки: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)]
  • Blood samples correlation [Срок оценки: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)]

Критерии участия

Критерии включения

  • Men or women ≥18 years of age
  • Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic
  • Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
  • Plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent
  • Able to provide informed consent and answer study questionnaires in either English or Spanish
  • Able to provide stool specimens for research purposes

Критерии исключения

  • Mental incapacity
  • Incarcerated individuals
  • Pregnancy (by self-report of pregnancy status)
  • Experiencing active brain metastasis/metastases
  • Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
  • Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Baptist Health Clinical Research — Elizabethtown

Идентификаторы

NCT: NCT05037825 · Pro00054854

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗