A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
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: Blood Samples for Biomarkers.
- Кому может быть актуально
- Состояния в реестре: Radiation Pneumonitis. 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
A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
Обзор
Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy. The purpose of this study is to: * Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis. * Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy. * Construct a predictive model for radiation pneumonitis. * Evaluate survival and treatment outcome of patients with radiation pneumonitis.
Подробное описание
1. Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital. 2. Follow up the enrolled patients. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0). 3. Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis. 4. Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis. 5. Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator. 6. Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment. 7. Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.
Вмешательства
- Другое Blood Samples for Biomarkers
blood sample to be taken at baseline, during radiotherapy, and after radiotherapy
Первичные конечные точки
- Radiation pneumonitis [Срок оценки: 12 months after radiotherapy]
- Overall Survival [Срок оценки: 5 years after radiotherapy]
Вторичные конечные точки (1)
- Other injuries induced by radiotherapy [Срок оценки: 5 years after radiotherapy]
Критерии участия
Критерии включения
- Clinical diagnosis of lung cancer by histology
- Radiation dose at least 45 Gy
- Karnofsky >60
- Age>18
- Life expectancy of at least 6 months
Критерии исключения
- Previous thoracic irradiation
- Severe cardiopulmonary diseases
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 3 центра
- Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technolo — Ухань
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
- Jingjiang People' Hospital — Jingjiang
Идентификаторы
NCT: NCT05448703 · TJCC012