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临床试验/NCT04918199
NCT04918199已完成不适用

Computer Based, vs Human Based Assessment of Kidney Allograft Failure Prediction and Stratification

Paris Translational Research Center for Organ Transplantation1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018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
发起方
入组人数
400
试验地点
1
主要终点
Death censored allograft failure seven years after risk assessment

研究概览

简要总结

The clinical decision-making after kidney transplantation is mainly driven by patient individual assessment. However, this task remains difficult and uncertain due to the integration of complex and numerous parameters. We aim to evaluate and compare the ability of transplant physicians to predict long term allograft survival compared with a computer-based survival prediction algorithm (iBox system).

详细描述

400 kidney transplant recipients among the cohort of 4,000 patients from the Paris Transplant Group prospective kidney transplant cohort (NCT03474003) were randomly selected. We generated an anonymized electronic health record for each included patient including a total of 60 classical kidney transplant prognostic parameters comprising baseline transplant and recipient characteristics, together with post-transplant parameters including allograft function, proteinuria, histology, diagnoses, and immunological profile collected during the first-year post-transplant. The time of risk evaluation for the human and the iBox system were at 1-year post transplant and the death censored allograft survival predictions made at 7 years after risk assessment. We enrolled transplant physicians at various stages of their careers (residents, fellows and seniors) to assign death censored graft survival probabilities at 7 years post risk assessment. The physicians were blinded to the actual patient outcome (allograft failure) and the iBox predictions. The physicians-based predictions will then be compared with the iBox system, a validated computer-based kidney survival prediction system.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • transplant evaluation available at one year post-transplant

排除标准

  • 未提供

结局指标

主要结局

Death censored allograft failure seven years after risk assessment

时间窗: 7 years

Predictions performances to predict allograft failure defined as a patient's definitive return to dialysis or preemptive kidney retransplantation after risk assessment.

次要结局

  • Evaluation of the parameters' importance in the prediction for physicians(7 years)
  • Inter-rater agreement(7 years)

研究者

发起方
Paris Translational Research Center for Organ Transplantation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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