Observational Study to Monitor the Effects of the COVID-19 Vaccine on Cancer Patients Receiving Active Therapy (ANTICOV).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of symptomatic patients affected by COVID-19
研究概览
简要总结
Based on recent data, COVID (COV) vaccination in cancer patients (pts) is strictly recommended. For oncologic pts,2 types of m-RNA vaccines have been approved: BNT162b2 (Pfizer, Biontech) and mRNA-1273 (Moderna, NIAID). In immunocompetent population, the administration of 2 doses confers 95% protection against COV. However, protection conferred by vaccines, adverse events (AEs) and correlations with antiblastic treatments are unknown in cancer pts.
详细描述
Trial Design
This is a monocentric observational study conducted by the Oncology Unit of Cremona (CR) Hospital, enrolling pts from Oncology, Hematology, Radiotherapy and Palliative Care of Cr Hospital.
This trial aims to prospectively and retrospectively evaluate the effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], the quantization of the antibodies (Abs) response and the onset of AEs in a consecutive population of 300 cancer pts, undergoing antiblastic treatment, starting from March 26Th,2021.
From March, 2021 a vaccination point was set up by Cr Hospital, specific for cancer pts. Vaccine is administered at least 5 days after the last dose of intravenous or oral chemotherapy treatment; the next course of therapy is not administered within the next 3 days. Target therapy and immunotherapy doesn't need interruptions.
- Primary endpoint: Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Cancer patients receiving active therapy (chemotherapy, immunotherapy, target therapy, radiotherapy)
- •Cancer patients receiving hormonal therapy for metastatic disease.
- •Must be ≥18 years of age.
- •Written, signed consent for study participation.
排除标准
- •Cancer patients receiving hormonal therapy in adjuvant regimen.
- •Patients in follow-up and who have completed their cancer treatment for > 6 months.
- •Life expectancy less than 3 months.
结局指标
主要结局
Number of symptomatic patients affected by COVID-19
时间窗: 7-60 days after the 2nd dose of vaccine
Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.
次要结局
- Antibodies variation at different timepoints(baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine)
- Adverse Events and interference between vaccine and cancer treatments(from 7 to 90 days after the 2nd dose of vaccine)