A Multicenter Prospective Diagnostic Test: Screening and Differentiating Common Cancers (Cancers of Lung, Stomach, Colorectum, Esophagus, Liver, Breast and Pancreas) Based on Peripheral Blood Cell-Free DNA Sequencing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,200
- 试验地点
- 8
- 主要终点
- diagnostic accuracy
研究概览
简要总结
The goal of this observational study is to screen and differentiate common cancers in participants with or without suspicious lesions. The main question the investigators aim to answer is: Can the developed model, using peripheral blood cell-free DNA sequencing, work well in screening and classifying common cancers especially in the early stages? Participants will undergo the collection of 15~20ml of blood and 1~2 telephone follow-up calls.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>20 and < 80 years old.
- •Cancer group: Newly diagnosed cancer patients with a confirmed pathological diagnosis within 90 days before blood collection or within 30 days after blood collection, including lung cancer, esophageal cancer, breast cancer, stomach cancer, colorectal cancer, liver cancer, and pancreatic cancer.
- •Non-cancer group: Individuals who have not been diagnosed with cancer during routine physical examinations and one-year follow-up.
排除标准
- •Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc.
- •New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids.
- •New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection.
- •Any cancer treatment performed within the past 3 years.
- •Individuals who have undergone organ or bone marrow transplantation.
- •Participants during pregnancy or lactation.
- •Individuals with malnutrition, severe mental illness, or genetic diseases.
- •Other diseases or conditions deemed by the physician as unsuitable for participation in this study.
- •Individuals who are unable to sign an informed consent form.
结局指标
主要结局
diagnostic accuracy
时间窗: Immediately after test completion
This refers to the ability of the test (peripheral blood cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers.
sensitivity
时间窗: Immediately after test completion
This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those with the disease. It is the proportion of true positive results (those with the disease who test positive) to the total number of individuals who actually have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
specificity
时间窗: Immediately after test completion
This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those without disease. It is the proportion of true negative results (those without the disease who test negative) to the total number of individuals who actually do not have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
次要结局
未报告次要终点
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China