跳至主要内容
临床试验/NCT06006845
NCT06006845招募中不适用

When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection

The Seventh Affiliated Hospital of Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Re-infection of COVID-19

研究概览

简要总结

The goal of this observational study is to study the safety of initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19. The main questions aims to answer are:

  • Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases adverse events related to antitumor therapy.
  • Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases risk of re-infection of COVID-19.
  • How initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 affects QoL of tumor patients

Participants will be asked to answer the question about:

  • the severity and duration of COVID-19 symptoms
  • the date of diagnosis of COVID-19
  • the date of negative nucleic acid test
  • the QoL of life before infection with COVID-19, during infection of COVID-19, after nucleic acid test negativity and receiving antitumor therapy

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • Tumor patients diagnosed with COVID-19 infection at our center from December 1, 2022 to May
  • COVID-19 was confirmed by antigen testing or nucleic acid testing.
  • Tumor was confirmed by pathology.
  • Patients received systemic antitumor therapy after infected with COVID-19.

排除标准

  • COVID-19 was not confirmed by antigen testing or nucleic acid testing
  • Tumor was not confirmed by pathology
  • Patients did not receive systemic antitumor therapy
  • Patients died before receiving systemic antitumor therapy

结局指标

主要结局

Re-infection of COVID-19

时间窗: 28 days after antitumor therapy

Antigen testing or nucleic acid testing positive for COVID-19

Incidence of adverse events after antitumor therapy

时间窗: 28 days after antitumor therapy

Incidence of adverse events after antitumor therapy, including hematologic toxicity,gastrointestinal adverse event, hepatobiliary adverse events, etc.

次要结局

  • Clinical manifestations of COVID-19 in tumor patients(Until nucleic acid testing turn negative)

研究者

发起方
The Seventh Affiliated Hospital of Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Bo

Professor

The Seventh Affiliated Hospital of Sun Yat-sen University

研究点 (1)

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