Proof of Concept (POC) Prospective Observational Study to Test a Framework for Integration of Data Streams, Including Molecular Genomic Markers and Wearable Device Data in Patients Receiving Chemotherapy for Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
The goal of this observational study is to collect biometric, HRQoL, immune response and genomic data continuously and intermittently during and after chemo or immunotherapy for the generation of a complex dataset using a platform which can aggregate different types of data collected over a time period and, to test the potential for analysis within and across data sets with linkage to clinical outcomes. The framework will have capabilities to integrate data from electronic medical records (EMRs) such as Epic, as well as digital streams including sensor, genomic, imaging and pathology. Such a platform can realise the potential for machine learning (ML) methodologies to address important cancer outcomes.
详细描述
The Investigators overarching aim is to determine the relationship between measures of physical performance status including heart rate and steps, health related quality of life (HRQoL) and genomic and immunogenomic phenotype on cancer outcomes in patients receiving chemotherapy or immunotherapy for haematological or metastatic cancer including renal (papillary, and RCC), breast, prostate, and other solid tumours. The primary objective is to test the feasibility of integrating diverse data streams (genomic, HR QoL and biometric) on a novel platform, capable of integrating data streams thus generating complex datasets for analyses using machine learning methodologies.
Secondary objectives will be to conduct exploratory analysis assessing the relationship between individual and combined data types and cancer outcomes.
Analysis using existing and novel computational models will be applied to the data to events in the acute and chronic setting that are common in patients diagnosed with cancer undergoing systemic therapy such as chemotherapy and immunotherapy. The outputs from this study will help inform future studies and trials designed to inform patients about their health status during cancer therapy
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
- •● A diagnosis of a metastatic or haematological cancer undergoing systemic therapy
- •Undergoing at least 1 planned cycle of chemotherapy or immunotherapy, according to standard of care practices.
- •Ability to understand and the willingness to sign a written informed consent.
- •Able to ambulate without assistance or walking aid.
- •Have an Android or iOS phone and willing to download the Ethera app
排除标准
- •● Physical disabilities that preclude daily walking
- •Inability to provide informed consent.
- •Unable to use and operate the Ethera Health Monitoring Smartphone App. (Apple or Android)
- •Medical or psychiatric condition which in the investigator's opinion would affect the successful completion of the study.
结局指标
主要结局
Primary Objective
时间窗: one month to 52 weeks
To measure feasibility of data collection longitudinally in a patient cohort undergoing systemic therapy for metastatic or haematological cancer.
Remote monitoring data
时间窗: one month to 52 weeks
To collect activity (steps) and heart rate data. This will be collected using the Ethera Wellness app which participants will download onto their smartphone devices.
Clinical Outcome data
时间窗: one month to 52 weeks
Data will be collected via an electronic case report form-
Biological sample data. This will include blood samples (30mls) maximum frequency will be monthly
时间窗: one month to 52 weeks
This will include blood samples (30mls) and stool samples maximum frequency will be monthly
Quality of life Questionnaire
时间窗: one month to 52 weeks
EORTC QLQ C30- questionnaire will be collected monthly
次要结局
未报告次要终点