Developing Artificial Intelligence-based Algorism Based on Life-log Data Acquired From Wearable Device for the Prediction of Chemotherapy-induced Side Effects and Symptom
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Developing artificial intelligence prediction algorism
研究概览
简要总结
In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.
The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.
详细描述
In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or older
- •Must have diagnosed with lung, head and neck, or esophageal cancer,
- •scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
- •scheduled for systemic chemotherapy due to recurrence or metastasis.
- •Eastern Cooperative Oncology (ECOG) performance status of 0 to
- •Patients who have access to a smartphone and can use the mobile app on their own.
- •Understand the purpose of the study and agree to participate in the study.
排除标准
- •Patients who, in the judgment of the researcher, have difficulty using the application.
- •Patients who are judged by the medical staff to be unable to participate in the study.
结局指标
主要结局
Developing artificial intelligence prediction algorism
时间窗: Through study completion, an average of 30 months
PRO data and treatment information collected from the wearable are used to evaluate correlations through methods such as linear regression to determine valid variables, utilizing LSTM models, etc.
次要结局
未报告次要终点
研究者
Sehhoon Park
M.D, Ph.D. Principal Investigator, Clinical Professor
Samsung Medical Center