A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12,500
- 试验地点
- 1
- 主要终点
- The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
研究概览
简要总结
PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.
详细描述
Participants will receive the OverC multi-cancer detection blood test along with standard-of-care screening, whose results will be returned to health care providers and participants. The diagnostic procedures will be guided firstly by the OverC multi-cancer detection blood test and then by the standard-of-care screening. The number, cancer types, and cancer clinical stage of cancer patients diagnosed via the OverC multi-cancer detection blood test will be recorded.
The study will enroll approximately 12,500 participants as defined by eligibility criteria with an anticipated enrollment period of approximately 9 months at up to 30 clinical sites within China. Participants will be actively followed for approximately 5 years from the date of their enrollment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be able to provide a written informed consent form
- •Participants must not have received any colonoscopy, abdominal MRI/CT, low-dose CT, or chest CT within 5 years before signing the informed consent form
- •Participants must be able to provide blood samples for study tests
- •Participants must be between 40 and 75 years old
排除标准
- •Individuals who have an acute infection or inflammation within 14 days prior to recruitment
- •Individuals with cancer-associated clinical symptoms or suspected of cancer
- •Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
- •Recipient of blood transfusion within 7 days prior to recruitment
- •Individuals who have pure ground-glass opacity
- •Unable to provide blood samples for the multi-cancer early detection blood test
- •Individuals who are unable to tolerate standard-of-care cancer screening tests or have contraindications of standard-of-care cancer screening tests
- •Individuals who have taken medication with anti-tumor effects within 30 days prior to recruitment
- •Individuals who have received or are undergoing curative cancer treatment within three years prior to recruitment
- •Individuals with hemorrhagic diseases
- •Individuals with autoimmune diseases
- •Individuals who are pregnant or lactating
- •Individuals who have severe comorbidities that are not suitable for participating in the trial judged by researchers
结局指标
主要结局
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
时间窗: Up to 5 years
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the multi-cancer detection test alone or with standard-of-care screening as evaluated after 1-year follow-up
时间窗: Up to 1 year
次要结局
- Changes in health-related quality of life in individuals with a positive result of the multi-cancer detection test assessed by Short Form Health Survey (SF-12v2)(Up to 5 years)
- Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test(Up to 5 years)
- Satisfaction with the multi-cancer detection test(Up to 5 years)
- Sensitivity, specificity, PPV, and NPV for the multi-cancer detection blood test alone or with standard-of-care screening as evaluated after 3- and 5-year follow-up(Up to 5 years)