Establishment of a Pan-Cancer Screening Model Based on Blood Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,000,000
- 试验地点
- 1
- 主要终点
- Area under the ROC curve (AUC)
研究概览
简要总结
This study aims to develop a pan-cancer screening model using routine blood biomarkers (including complete blood count, biochemical tests, coagulation panel, and tumor markers). The study is retrospective, collecting data from approximately 10,000,000 cancer patients diagnosed at multiple centers in China between January 2006 and September 2025. All patients have confirmed pathological diagnosis and complete blood test records. A Mixture of Experts (MoE) machine learning model will be built to predict the presence of various cancers (e.g., gastric, colorectal, liver, lung, ovarian cancer). The goal is to establish a low-cost, non-invasive screening tool suitable for large-scale population screening.
详细描述
Background: Cancer is a leading cause of death worldwide. Early detection improves survival, but current screening methods (e.g., endoscopy, imaging) are invasive, costly, or not widely accessible. Blood-based biomarkers offer a non-invasive, repeatable, and cost-effective alternative.
Objective: Primary: To establish a pan-cancer screening model based on blood biomarkers. Secondary: To combine multiple blood markers for identifying high-risk populations. Exploratory: To develop a cost-effective, scalable screening technology.
Study Design: This is a multicenter, retrospective study. Data will be collected from 15 participating hospitals in China, including Zhejiang Cancer Hospital, Tongling People's Hospital, Pingyang People's Hospital, Fenghua People's Hospital, Shaoxing Central Hospital, Bingqi General Hospital, the Second Affiliated Hospital of Jiaxing University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Yunnan Cancer Hospital, Xianju People's Hospital, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No.9 Hospital Ningbo, Norinco General Hospital, Quzhou Kecheng People's Hospital.
Participants: Approximately 10,000,000 patients aged 18-80 years with pathologically confirmed cancer (including respiratory, digestive, urogenital, nervous, endocrine, and soft tissue malignancies). Exclusion criteria: presence of non-cancer organic diseases, hematologic disorders, immunodeficiency (e.g., AIDS), or incomplete data.
Data collection: Blood biomarkers including complete blood count, biochemical tests (liver/kidney function, glucose, lipids), coagulation (PT, APTT, TT, fibrinogen), and tumor markers (e.g., CEA, CA19-9, AFP, CA125, etc.) along with clinical data (age, sex, height, weight, diagnosis) will be extracted from medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathologically confirmed cancer patients (for case group) OR individuals without cancer (for control group)
- •Age between 18 and 80 years
- •Complete clinical data and blood test results (complete blood count, biochemistry, coagulation panel, tumor markers) available
- •No history of other organic diseases (excluding cancer)
排除标准
- •Presence of organic diseases other than cancer (e.g., severe heart, liver, kidney disease)
- •Hematologic disorders or immunodeficiency diseases (e.g., AIDS)
- •Incomplete data or missing timeline records
研究组 & 干预措施
All Participants
All enrolled individuals (cancer patients and non-cancer controls) with retrospective blood biomarker data.
干预措施: No intervention (Other)
结局指标
主要结局
Area under the ROC curve (AUC)
时间窗: At study completion, approximately December 2030
AUC of the MoE model for discriminating cancer from non-cancer controls.
Sensitivity of the model
时间窗: At study completion, approximately December 2030
True positive rate of the pan-cancer screening model.
Specificity of the model
时间窗: At study completion, approximately December 2030
True negative rate of the pan-cancer screening model.
次要结局
未报告次要终点
研究者
Xiangdong Cheng
Professor and Principal Investigator
Zhejiang Cancer Hospital