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临床试验/NCT04567979
NCT04567979已完成不适用

Prospective Determination of COVID-19 Infection Rate in Patients With Solid Tumors and Healthcare Workers of the Chemotherapy and Radiotherapy Unit at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
1
主要终点
SARS-CoV-2 infection rate in patients with solid tumors.

研究概览

简要总结

Cancer patients are considered vulnerable to COVID-19 infection. During the pandemic, cancer patients may need to continue their regular treatment of chemotherapy and / or radiotherapy and therefore must visit a hospital unit. As such, they may be at risk for SARS-CoV-2 infection by means of close contact to other patients and health care workers. Hospitals may implement policies to identify symptomatic subjects and limit their access to the chemotherapy / radiotherapy unit. However, asymptomatic COVID-19 positive patients may escape these filters and potentially be contagious to other patients and their health-related workers that care for other several patients. Therefore, there is a real risk of an outbreak that affects a particularly fragile patient population. Patients and their doctors need to know what is the risk associated to visiting a chemotherapy unit in order to decide if the risk outweighs the benefits of cancer treatment in their particular case. To date, this risk is unknown. The study will test patients and health care workers for COVID-19 infection during the peak of the pandemic in a chemotherapy unit in Mexico in order to determine this risk.

详细描述

In this is prospective cohort, patients with solid tumors and healthcare workers of the chemotherapy and radiotherapy unit at our center will be followed with a daily digital survey and optionally with biweekly PCR tests for SARS-CoV-2. People with symptoms and / or with a positive PCR test for SARS-CoV-2 will be notified and recommendations according to clinical state will be emitted.

Hypothesis

COVID-19 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy will be less than 5% during the pandemic period.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with solid tumors receiving active oncological treatment (chemotherapy, or radiotherapy or biologic therapy) at our center.
  • Age: no limit
  • Gender: men and women.
  • Health-related worker treating patients with solid tumors at the chemotherapy and radiotherapy unit at our center.
  • People who sign an informed consent.

排除标准

  • Patients with an hematologic cancer.
  • Patients with cancer under surveillance or without active oncological treatment, or receiving treatment in another center.

结局指标

主要结局

SARS-CoV-2 infection rate in patients with solid tumors.

时间窗: From June 2020 to September 2020.

Determination of SARS-CoV-2 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy during the pandemic period.

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Huitzil m

Médico Especialista A

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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