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Идёт набор NCT06181656

Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation

— Наблюдательное Pneumococcal Vaccine Esophageal Cancer Lymphopenia Chemoradiation

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: Pneumonia vaccine.
Кому может быть актуально
Состояния в реестре: Pneumococcal Vaccine, Esophageal Cancer, Lymphopenia, Chemoradiation. 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

To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Подробное описание

Primary Objectives

\- Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.

Secondary Objectives

* Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination. * Determine the impact of radiation modality on serologic responses to pneumococcal vaccination. * Determine the impact of radiation modality on systemic immunity. * Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine. * Determine the impact of radiation modality on pathologic response. * Determine the impact of radiation modality on intratumoral immunity. * Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response) * Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.

Вмешательства

  • Биопрепарат Pneumonia vaccine
    Given by SC

Первичные конечные точки

  • Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination [Срок оценки: through study completion; an average of 1 year]

Критерии участия

Критерии включения

  • Group 1A

a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.

  • Group 1B

a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)

  • Group 2A

a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer.

  • Group 2B

a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.

  • Group 3

a. Healthy age- and gender- matched individuals

  • All Groups
  • Patients of all genders, races and nationalities will be solicited.
  • Age >18 years
  • Ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

  • Patients with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy

a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

  • Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Individuals with previous pneumococcal vaccination in the last 5 years.
  • Individuals with severe allergy to any of the vaccine components

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06181656 · 2023-0370 · NCI-2023-10646

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗