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临床试验/NCT04569292
NCT04569292Unknown不适用

Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study

Ospedale Andrea Tortora di Pagani1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
describe cancer patients with COVID-19 and their clinical course

研究概览

简要总结

It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.

Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection

详细描述

Primary objectives:

  • describe cancer patients with COVID-19 and their clinical course;
  • identify predictors of the most severe clinical course;
  • identify prognostic factors; Secondary objectives
  • Monitor patients with urological tumors with particular attention;
  • Dosing parameters of inflammation such as IL-6 and IFNα;
  • Measure the ACE2 levels.

Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • confirmation of COVID-19 in the laboratory (RT-PCR techniques);
  • suspected cases of COVID-19; clinically diagnosed based on symptoms (fever> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
  • asymptomatic cases; diagnosed based on positive swab results but without symptoms even dead patients

排除标准

  • 未提供

结局指标

主要结局

describe cancer patients with COVID-19 and their clinical course

时间窗: Almost 1 year

Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors

次要结局

未报告次要终点

研究者

发起方
Ospedale Andrea Tortora di Pagani
申办方类型
Network
责任方
Sponsor

研究点 (1)

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