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临床试验/NCT04418245
NCT04418245撤回不适用

Identification of Thoracic CT Scan Biomarkers by Deep Learning for Evaluating the Prognosis of Patients With COVID-19 Disease

Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
1,000
试验地点
6
主要终点
Patient requiring more than 3 liters of oxygen to maintain a saturation >95% (intensive care unit or resuscitation department)

研究概览

简要总结

The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificial intelligence by deep learning would generate imaging biomarkers linked to the patient's short- and medium-term prognosis.

The purpose of this study is to rapidly make available an early decision-making tool (from the first hospital consultation of the patient with symptoms related to SARS-CoV-2) based on the integration of several biomarkers (clinical, biological, imaging by thoracic scanner) allowing both personalized medicine and better anticipation of the patient's evolution in terms of care organization.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients positive for SARS-CoV-2 according to RT-PCR test between 1st March and 31st May 2020
  • Patients undergoing low dose CT scan to establish Covid-19 lung damage
  • Available for at least 8 days follow-up

排除标准

  • Patients opposing the retrospective use of their data

结局指标

主要结局

Patient requiring more than 3 liters of oxygen to maintain a saturation >95% (intensive care unit or resuscitation department)

时间窗: Day 8

Yes/no

Percentage of lung affected by condensation on scan

时间窗: Day 0

% calculated by deep learning

Percentage of lung affected by ground glass opacity on scan

时间窗: Day 0

% calculated by deep learning

Vital status

时间窗: Day 8

Dead/alive

Percentage of lung affected on CT

时间窗: Day 0

% ground glass and condensation calculated by deep learning

次要结局

  • rehospitalization(Day 30)
  • Duration of intubation(Day 30)
  • D Dimers level(Admission Day 0)
  • Time between RT-PCR positive results and first scan(Admission Day 0)
  • Medical history of cardiovascular disease(Admission Day 0)
  • Percentage of lung affected on CT(Day 16)
  • C-reactive protein levels(Admission Day 0)
  • Time until onset of symptoms(Admission Day 0)
  • BMI> 30(Admission Day 0)
  • lymphocytemia(Admission Day 0)
  • Diabetes(Admission Day 0)
  • Medical history of immunosuppressed condition(Admission Day 0)
  • Vital status(Day 30)
  • Length of hospitalization(Maximum 30 days)
  • Percentage of lung affected by ground glass opacity on scan(Day 16)
  • Percentage of lung affected by condensation on scan(Day 16)
  • Software operating time(End of study (August 2020))
  • Calculate a prognostic score from clinical, biological and CT parameters(Day 8)
  • lactate dehydrogenase(Admission Day 0)
  • Calculate a prognostic score from clinical and biological parameters only(Day 8)
  • Medical history of respiratory disease(Admission Day 0)
  • Age(Admission Day 0)
  • Current or previous history of smoking(Admission Day 0)
  • Compare receiver operating curves of prognostic scores with and without CT parameters(Day 8)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (6)

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