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