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临床试验/NCT04771559
NCT04771559已完成不适用

Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients

Bezmialem Vakif University6 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
6
主要终点
Antibody levels

研究概览

简要总结

The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer and compare them with the healthy control group.

详细描述

The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer. Patients followed up in medical oncology clinic and healthy volunteers will be enrolled in the study. Blood samples of participants will be taken 4 weeks after the second dose of the COVID-19 vaccine. After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different eppendorf tubes and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples. In addition, volunteers will be questioned in terms of side effects that may develop after vaccination and the information obtained will be recorded in the database together with the clinical data of the patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the patient group :
  • Patients with pathological and clinical cancer diagnosis
  • Older than 18 years
  • Patients two doses of COVID-19 vaccine administered
  • Volunteering to participate in the study
  • For the control group :
  • No known cancer diagnosis or history
  • Older than 18 years
  • Two doses of COVID-19 vaccine administered
  • Volunteering to participate in the study -

排除标准

  • Not volunteering to participate in the study
  • < 18 years
  • Not administered two doses of the COVID-19 vaccine
  • Covid-19 infection history -

结局指标

主要结局

Antibody levels

时间窗: 1 month

COVID-19 antibody titers of the patients will be measured in blood samples.

次要结局

  • Side effects(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe İrem Yasin

MD

Bezmialem Vakif University

研究点 (6)

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