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Идёт набор NCT06168032

COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

Без фазы С лечением COVID-19 Recurrent Lung Cancer Vaccination Antibody

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: Any Chinese government-recommended COVID-19 booster vaccine.
Кому может быть актуально
Состояния в реестре: COVID-19 Recurrent, Lung Cancer, Vaccination, Antibody. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in the Management of Lung Cancer Patients With Systemic Anti-cancer Treatment

Обзор

A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.

Подробное описание

A single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic COVID-19 infection and status including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. For antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose vaccination.

Вмешательства

  • Биопрепарат Any Chinese government-recommended COVID-19 booster vaccine
    Any Chinese government-recommended COVID-19 booster vaccine(such as Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine(Sf9 Cell) and so on) will be once administered in the sixth month after COVID19 infection.

Первичные конечные точки

  • Incidence of recurrent symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection. [Срок оценки: up to 8 weeks]
Вторичные конечные точки (5)
  • Incidence of critical and/or severe symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection. [Срок оценки: up to 8 weeks]
  • All-cause mortality rate [Срок оценки: up to 8 weeks]
  • Overall survival [Срок оценки: up to 8 weeks]
  • Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [Срок оценки: up to 8 weeks]
  • Incidence of adverse events following immunization [Срок оценки: up to 8 weeks]

Критерии участия

Критерии включения

  • Patients who agree to participate in the trial and sign the informed consents.
  • Male or female, ≥18 years old.
  • Diagnosed of lung carcinoma by histological and cytological examinations.
  • Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
  • Recorded history of COVID19 infection.
  • Sufficiently functional organs.
  • Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.

Критерии исключения

  • Life expectance less than 3 months.
  • Less than 3 months since last confirmed COVID-19 infection.
  • Patients unable to return the hospital for follow-up.
  • Patients allergic to COVID-19 vaccine.
  • Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06168032 · K4846

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗