Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,527
- 试验地点
- 4
- 主要终点
- Feasibility of MCED in the intended use setting.
研究概览
简要总结
This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.
详细描述
Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol.
Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app.
Participants will be actively followed for 1 year from the date of the blood draw.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-74 years old
- •Able to provide a written informed consent and willing to comply with all parts of the protocol procedures
排除标准
- •With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
- •Have definite contraindications of cancer screening examination and diagnostic procedures
- •Unable to comply with the protocol procedures
- •Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
- •Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
- •Recipients of anti-tumor therapy within 30 days prior to screen
- •Pregnancy or lactating women
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 7 days prior to screen
- •With autoimmune diseases
- •Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
- •Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)
研究组 & 干预措施
Healthy subjects
干预措施: multi-cancer early detection (Device)
结局指标
主要结局
Feasibility of MCED in the intended use setting.
时间窗: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED.
Safety of MCED in the intended use setting.
时间窗: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued.
次要结局
- Clinical utility of MCED alongside SOC screening.(From enrollment to the Follow-up at 1 year)
- Performance of MCED in the intended use setting.(From enrollment to the Follow-up at 1 year)
- Cancer signal origin accuracy of MCED.(From enrollment to the Follow-up at 1 year)
- Participant-reported psychological impact.(From enrollment to the Follow-up at 1 year)
- Participant-reported health related quality of life (HRQoL) .(From enrollment to the Follow-up at 1 year)