A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy
研究概览
简要总结
The purpose of this study is to investigate the impact of COVID -19 in the cancer patient population. This will be done by looking at the rate of asymptomatic COVID-19 infection in cancer patients receiving cancer therapy, as well as their immune response.
This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network (UHN) and other centers.
详细描述
Given increasing community transmission and the possibility of asymptomatic carriage of virus, it is important to study whether asymptomatic shedders of virus are playing a role in propagating the pandemic. There is currently little data available regarding cancer patients, yet, this population may be particularly susceptible to the COVID-19 infection.
Despite the cancer patient population being at higher risk of COVID-19, no systematic screening has been established and no biomarkers have been identified to determine which patient is at higher risk.
This study will screen patients on active cancer therapy for COVID-19 as a standard of care or a research nasopharyngeal test. Blood samples may also be taken to assess any patient response to the virus and optional saliva samples may also be taken to assess the feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production (eg. secondary to cancer treatments such as radiation, chemotherapy, and/or surgery).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having an active malignancy who are planned to start therapy within 6 weeks of consent or are receiving a treatment for active malignancy.
- •The patient falls under either of the following categories:
- •Asymptomatic for COVID-19 (as per daily screening at the hospital entrance).
- •Has symptoms similar to those of COVID-19 (e.g. fever or flu-like symptoms such as cough or shortness of breath) that are assessed by the overseeing Investigator as being related to disease and unrelated to COVID-19 infection.
- •Note: Patients who recovered from previous COVID-19 infection will be eligible.
- •No contraindication to performing a NP swab and blood work.
排除标准
- •Any patients with fever, or flu-like symptoms assessed by the Investigator to be related or potentially related to COVID-19 infection will not be eligible.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 3-4
结局指标
主要结局
Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy
时间窗: 12 months
次要结局
- Describe the clinical course of COVID-19 infection in cancer patients(12 months)
- Rate of sero-conversion in cancer patients(12 months)