To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Detection of SARS-CoV-2 antibodies of all patients
研究概览
简要总结
For tumor patients, the virus antibody titer produced by the SARS-CoV-2 vaccine is often lower than that of normal people in a short period of time, but in the long run, it can significantly reduce the infection rate and fatality rate of the new coronavirus, and the adverse reactions are mild and there is no significant difference with normal people. However, there is still no real-world research data in China to prove the protective effect of the SARS-CoV-2 vaccine on patients with tumors infected with the SARS-CoV-2 virus.
详细描述
To explore the protective effect of SARS-CoV-2 vaccination on cancer patients infected with SARS-CoV-2. Serum samples were collected from cancer patients who had been infected with SARS-CoV-2 and were previously vaccinated or unvaccinated. The SARS-CoV-2 antibodies (IgG and IgM concentrations) were detected by micro-magnetic particle chemiluminescence method, and the differences were compared. The results of this real-world prospective cohort study can be used to guide the vaccination of cancer patients in clinical practice.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years old, regardless of gender;
- •patients with previous or current tumor, regardless of tumor type;
- •have a history or current infection with SARS-CoV-2;
- •The vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction;
- •those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent.
排除标准
- •Those who do not meet the inclusion criteria or diagnostic criteria, and cannot cooperate with blood sampling and arrangement;
- •patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia;
- •local skin ulceration affecting blood drawing, severe rash, or infectious diseases;
结局指标
主要结局
Detection of SARS-CoV-2 antibodies of all patients
时间窗: 2022.12-2022.6 Clear experimental scheme;Serum antibody detection and data collection were completed 2022.7-2022.8 The follow-up data analysis was completed 2022.8-2022.9 Conduct the writing and submission of the paper
Detection of SARS-CoV-2 antibodies (IgG and IgM concentrations) by micro-magnetic particle chemiluminescence method of all patients
次要结局
未报告次要终点