Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 vaccine response at 12 months
研究概览
简要总结
In the context of malignant disease, it is likely that vaccine efficacy and immunogenicity depends on the type of pathology, stage of the disease, immunosuppression induced by the treatments, in addition to more classic factors such as age, general condition and possibly the type of vaccine used.
There are very little data on the efficacy and immunogenicity of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with malignant disease in the active phase of treatment.
This multicenter observational study aims to assess the efficacy and the immunogenicity of anti-Sars-CoV-2 vaccines in the cohort of patients treated for malignant pathology (solid or hematological tumors) at Saint Louis Hospital and in thoracic oncology patients at Bichat Hospital.
详细描述
During the visit carried out as part of the follow-up, participation in this study will be proposed to any patient who is treated for a malignant disease (solid or hematological tumors) within the university hospitals of AP-HP.Nord.
The patients participating in this prospective cohort will benefit from all standard care his/her condition requires.
Clinical and biological data will be collected as part of the usual follow-up. Clinical data: pathology, stage, treatment line, type of current treatment and date of the last treatment administered, previous treatments, radiotherapy, concept of radiation lung disease, history of pneumonectomy, comorbidities, performance status, history of coronavirus disease 2019 (COVID-19).
Laboratory data: pre-vaccination polynuclear neutrophil count, lymphocyte counts, plasma protein electrophoresis or Ig weight dosage (routine care in hematology), lactate dehydrogenase (LDH), C-reactive protein (CRP), albuminemia in the previous month.
Vaccination data: type of vaccine, date of the 1st injection, date of the 2nd injection, pre-vaccination antibody levels
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant disease undergoing treatment at Saint Louis Hospital or Bichat Hospital (for chest cancer)
- •with chemotherapy
- •with chemotherapy + Immunotherapy
- •with immunotherapy
- •with targeted therapies
- •with radiotherapy
- •in the event of radiation pneumonitis after radiotherapy for lung cancers
- •after pneumonectomy for lung cancer
- •Patient informed and having expressed their non-opposition to participating in this research
排除标准
- •Patient with a contraindication to Sars-Cov2 vaccination
结局指标
主要结局
SARS-CoV-2 vaccine response at 12 months
时间窗: 12 months
IgG anti-Sarc-CoV-2 S-protein titer at 12 months
次要结局
- SARS-CoV-2 vaccine response at 3 months(3 months)
- Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination(Day 0)
- SARS-CoV-2 vaccine response after first dose of vaccine(Day 24 +/- 4 days)
- Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination(Day 0)
- SARS-CoV-2 vaccine response at 6 months(6 months)
- SARS-CoV-2 vaccine safety in the study population(12 months)