NCT05043220进行中（未招募）不适用
COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •gynecological cancer
- •indication for systemic cancer therapy
- •patients who are legally competent and able to understand and follow instructions of the study staff
- •present informed consent
排除标准
- •no use if internet or applications
- •persons who are in a dependency or employment relationship with the study center
- •positive proof of COVID-19
- •affection of the external auditory canal
结局指标
主要结局
Compliance
时间窗: 3 months
Compliance is defined as wearing time of the in-ear-sensor.
robustness of the ppg-signal
时间窗: 3 months
number and duration of the ppg-signal transmitted
次要结局
- number of contacts and hospitalization rates(3 months)
- infections(3 months)
- number of correct- and false-positive alerts(3 months)
- OS; PFS(3 months)
- therapy modifications(3 months)
- effect on quality of life(3 months)
- health-related costs(3 months)
研究者
Heike Jansen
Principal Investigator
Technical University of Munich
研究点 (2)
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