跳至主要内容
临床试验/NCT04531995
NCT04531995招募中不适用

Development of an Artificial Intelligence-based Incident Prediction Algorithm to Improve Cancer Patient Care and Patient Safety

Cankado GmbH4 个研究点 分布在 1 个国家目标入组 166,000 人开始时间: 2022年8月3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
Cankado GmbH
入组人数
166,000
试验地点
4
主要终点
Presence or Absence of dosis reductions

研究概览

简要总结

The OMCAT Register aims to provide learning databases in cancer comprising both PRO data using PRO-React and "ground truth" (outcome data verified by the physician during patient examinations). Intelligent learning and knowledge engineering procedures will utilize this PRO data to provide high-quality event prediction algorithms. The ground-truth data enables so-called "supervised learning" techniques of artificial intelligence, because predicted events can be verified with a high level of certainty from ground-truth data.

详细描述

The next generation of PRO-React by CANKADO is designed to predict impending incident threats at an earlier stage than previously feasible and -- by more timely intervention -- help physicians to eliminate or mitigate the severity of an unfavourable event, reduce the required intensity of countermeasures, or otherwise reduce patient risks.

A highly reliable identification of situations classified as "low-risk" by CANKADO could also enable a more focused utilization of resources as well as enhanced patient comfort and decreased stress, e.g., due to less frequent monitoring visits or reduced need for invasive diagnostics.

The OMCAT Register aims to provide learning databases in cancer comprising both PRO data using PRO-React and "ground truth" (outcome data verified by the physician during patient examinations). Intelligent learning and knowledge engineering procedures will utilize this PRO data to provide high-quality event prediction algorithms. The ground-truth data enables so-called "supervised learning" techniques of artificial intelligence, because predicted events can be verified with a high level of certainty from ground-truth data.

The PRO data of a patient provide what is known in engineering, physics, and statistics as "time series" of observations. The unique feature of PRO time series for applications in cancer is the very high "sampling frequency" (e.g., daily or better) compared to examinations, which generally occur at fixed, and much less frequent intervals. Prediction algorithms based on PRO data would thus be ideally suited to reduce the delay in detecting events, for example, by triggering physician appointments or indicating the need for more intensive medical diagnostics.

研究设计

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

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

  • Signed informed consent
  • Age ≥ 18 years
  • Diagnosed with cancer
  • Prescribed CANKADO PRO-React Onco

排除标准

  • Lack of consent to study participation or lack of patient's ability to consent
  • Enrolled in this trial within a further treatment

结局指标

主要结局

Presence or Absence of dosis reductions

时间窗: 6 months

yes/no (answered by physician)

Presence or Absence of treatment interruptions

时间窗: 6 months

yes/no (answered by physician)

Health Status

时间窗: 6 months

Using the EuroQol-visual analogue scale, abbreviated as EQ-VAS Scale, containing values between 100 (best imaginable health) and 0 (worst imaginable health), (answered by patients)

Presence or Absence of death

时间窗: 6 months

yes/no (answered by physician)

Presence or Absence of SAEs

时间窗: 6 months

yes/no (answered by physician)

Complaints/Symptoms

时间窗: 6 months

Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)

Presence or Absence of disease progression

时间窗: 6 months

yes/no (answered by physician)

Presence or Absence of disease regression

时间窗: 6 months

yes/no (answered by physician)

次要结局

  • Patient Typology(6 months)
  • Timepoints of patient documentation(6 months)
  • Cancer type(6 months)
  • Frequency of patient documentation(6 months)

研究者

发起方
Cankado GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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