Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule--A Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to progression of pulmonary nodules
研究概览
简要总结
The objective of this study is to assess the inoculation-related symptoms and long-term effects of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting. The investigators aim to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.
详细描述
This study will enroll lung cancer/pulmonary nodule patients or healthy people who had undergone standard vaccination procedures against SARS-CoV-2/COVID-19. This observatory study will apply an electronic questionnaire to collect general information and post-vaccination symptoms or adverse events of vaccinated pulmonary nodules/lung cancer patients and healthy control. The researchers will further analyze whether the vaccine will promote the progression of primary tumors/pulmonary nodules through long-term follow-up. The investigators aim to assess the adverse events and long-term impact of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting, to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who have been vaccinated against the SARS-CoV-2
- •Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who are not vaccinated against the SARS-CoV-2
- •Healthy people who have been vaccinated against the SARS-CoV-2
排除标准
- •Multiple malignancy in other parts of body;
- •Infected with SARS-CoV-2 virus currently or in the past;
- •Refuse to participate in this study.
结局指标
主要结局
Time to progression of pulmonary nodules
时间窗: The date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan, up to 12 months
Time calculated from the date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan
Occurence rate of vaccination-related adverse effects
时间窗: Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation
Occurence rate of vaccination-related adverse effects in case group and healthy control group
Time to recurrence of lung cancer
时间窗: The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months
Time calculated from the date of vaccine inoculation to the date of reported recurrence of lung cancer confirmed by pathological examination
次要结局
- Duration of vaccination-related adverse effects(Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation)
- Severity of vaccination-related adverse effects(Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation)
研究者
GuiBin Qiao
Administrative Director, Department of Thoracic Surgery
Guangdong Provincial People's Hospital