ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,000
- 试验地点
- 77
- 主要终点
- Changes to Cancer Treatments
研究概览
简要总结
The American Society of Clinical Oncology (ASCO) Survey on Coronavirus 2019 (COVID-19) in Oncology Registry (ASCO Registry) aims to help the cancer community learn more about the patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how COVID-19 is impacting the delivery of cancer care and patient outcomes. The ASCO Registry collects both baseline and follow-up data on how the virus impacts cancer care and cancer patient outcomes during the COVID-19 pandemic.
详细描述
Rationale:
The COVID-19 Pandemic presents a unique opportunity to capture information on how a disease outbreak affects delivery of high-quality cancer care. ASCO is providing the means for the oncology community to rapidly submit data that will inform both current cancer care and provide information to help guide decision-making for future disease outbreaks. While other entities have launched COVID-19 cancer registries, ASCO's registry collects information about patients undergoing treatment for cancer and with confirmed COVID-19 infection based on a positive test. Unlike other registries, ASCO's registry collects follow-up information on both COVID-19 disease and cancer outcomes at 30-day intervals for the first 90 days and 90-day intervals thereafter up to one year after COVID-19 diagnosis.
Project Objectives:
Capture and describe cancer and COVID-19 status at COVID-19 diagnosis, and cancer and COVID-19 outcomes of patients with cancer and COVID-19 from participating cancer practices/institutions. Data collected includes treatment approaches, cancer status, changes to cancer treatment plans in patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, status of COVID-19 infection (e.g., severity of symptoms, need for ventilator, hospitalization, etc.) and cancer (e.g., cancer progression, treatment-related changes/modifications, etc.).
Research Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 positive diagnosis
- •One of the following;
- •Patient has active cancer at the time of COVID-19 diagnosis OR
- •Patient has been cancer-free for less than 12 months AND receiving adjuvant therapy at the time of COVID-19 diagnosis
排除标准
- •COVID-19 suspected, but no positive test result
- •Patient is a cancer-free not receiving any anti-cancer or adjuvant treatment
- •Patient is receiving adjuvant therapy, but has been cancer-free for up to 12 months at the time of COVID-19 diagnosis
结局指标
主要结局
Changes to Cancer Treatments
时间窗: 24 months
Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics
次要结局
- COVID-19 Treatments(24 months)
- Patient vital status(24 months)
- Overall survival(24 months)
- Patient cancer status (for patients who are disease-free at COVID-19 diagnosis)(24 months)
- All-cause mortality at 30 days(30 days)
- COVID-19 Symptoms(24 months)
- Patient cancer status (for patients who had active cancer at covid-19 dx)(24 months)