Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 839
- 试验地点
- 8
- 主要终点
- Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
研究概览
简要总结
The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are:
- Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
- Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library.
Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old and ≤70 years old;
- •Plasma of the participant can be obtained;
- •Willing to sign the informed consent;
- •Meet one of the following criteria:
- •4.1)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia;
排除标准
- •In any of the following situations, subjects should not participate in the trial:
- •Pregnant or lactating;
- •Unable to obtain the participant's plasma;
- •Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
- •The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
- •Received any blood product transfusion in the past 30 days;
- •Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.
结局指标
主要结局
Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
时间窗: 1 year from enrollment
Peripheral blood samples were collected during routine physical examinations for healthy volunteers and prior to surgery for cancer patients. The blood samples were drawn and placed into cfDNA preservation tubes (Ardent BioMed, Guangdong, China, Cat. # BY10240301). After collection, the fresh blood was subjected to an initial centrifugation at 1,600 × g for 10 minutes at 4°C, allowing the plasma supernatant to be carefully separated via pipetting. This plasma was then centrifuged again at 16,000 × g for 10 minutes at 4°C to remove any residual debris. The resulting plasma supernatant was then carefully collected and stored at -80°C. The preserved plasma samples were subsequently transported on dry ice to the central laboratory at OmixScience Research Institute (Hangzhou, China).
次要结局
- Evaluate participants' TeFei™ score(60 days)
研究者
Ni Chao
Associate Chief Physician of Breast Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University