Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule
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: Traditional Chinese Medicine.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Nodule, Cohort Study, Traditional Chinese Medicine. Базовые параметры: Без ограничений · 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
Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule （RESEARCH-PN）
Обзор
This study is a prospective multicenter cohort study that primarily evaluates the impact of traditional Chinese medicine treatment on pulmonary nodules
Подробное описание
This study is a multicenter, prospective cohort study that will recruit at least 2244 individuals with chest HRCT findings of pulmonary nodules and recommended follow-up by MDT from four research centers. According to whether patients with pulmonary nodules are treated with traditional Chinese medicine, they are divided into a traditional Chinese medicine cohort and a non-traditional Chinese medicine cohort , and are followed up for at least 2 years. The main outcome measures were pulmonary nodule growth (enlargement or new onset) and nodule regression (reduction or disappearance). To evaluate the efficacy of traditional Chinese medicine treatment for patients with pulmonary nodules, secondary outcome measures include nodule volume, average nodule density, doubling time of volume, internal and external signs of nodules, anxiety self-assessment scale, depression self-assessment scale and SF-36 scale.
Вмешательства
- Препарат Traditional Chinese Medicine
Received treatment with traditional Chinese medicine
Первичные конечные точки
- Pulmonary nodule growth [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- Pulmonary nodule regression [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
Вторичные конечные точки (9)
- Nodule stability [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- Pulmonary nodule volume [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- Mean density of pulmonary nodules [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- Doubling time of pulmonary nodule volume [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- Internal signs of pulmonary nodules [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- External signs of pulmonary nodules [Срок оценки: Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.]
- self-rating anxiety scale [Срок оценки: Scale will be measured at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. A score of 50-59 is defined as mild anxiety, and 60-69 is defined as moderate anxiety , and a score of 70 or above is defined as severe anxiety.]
- self-rating depression scale [Срок оценки: Scale will be measured at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. A score of ≥ 53 indicates the presence of depression.]
- SF-36 scale [Срок оценки: Scale will be measured at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.The scores in all aspects are from 0 to 100 points, and the higher the score, the better the quality of life.]
Критерии участия
Критерии включения
① Patients with pulmonary nodules and recommended for follow-up by MDT; ② Voluntarily sign the informed consent form.
Критерии исключения
①Patients with metastatic pulmonary nodules; ②Patients with benign diseases such as pulmonary lymph nodes, hamartomas, sclerosing alveolar cell tumors, or nodules with obvious benign features such as calcification; ③Patients withserious heart, lung, liver and kidney 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 · 1 центр
- The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine — Чжэнчжоу
Идентификаторы
NCT: NCT06673121 · RESEARCH-Pulmonary nodule