A Multi-center, Perspective, Observational Case-control Study to Develop and Validate an Ovarian Cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 3
- 主要终点
- The performance of cfDNA methylation-based model for discriminating ovarian cancer versus non-cancer.
研究概览
简要总结
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from newly diagnosed ovarian cancer.
详细描述
Peripheral blood samples from ovarian cancer (OC) patients will be prospectively collected to identify cancer-specific circulating signals by analyzing cell free DNA. Based on the comprehensive molecular profiling, a machine learning-driven noninvasive test will be trained and validated through a two-stage approach in clinically annotated individuals. Approximately 168 stage I-II OC patients will be enrolled in this study. Age-matched female controls included in model development were recruited in another study, which are volunteers without a cancer diagnosis after routine medical screening.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •40-75 years old
- •Clinically and/or pathologically diagnosed ovarian cancer
- •No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- •Able to provide a written informed consent and willing to comply with all part of the protocol procedures
排除标准
- •Pregnancy or lactating women
- •Known prior or current diagnosis of other types of malignancies comorbidities
- •Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 30 days prior to study blood draw
- •Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- •Other conditions that the investigators considered are not suitable for the enrollment
结局指标
主要结局
The performance of cfDNA methylation-based model for discriminating ovarian cancer versus non-cancer.
时间窗: 12 months
Sensitivities of cfDNA methylation-based model in detecting OC at specificity of 99% and 95%, respectively.
次要结局
- The performance of model using multi-omics data for discriminating ovarian cancer versus non-cancer(12 months)
- The performance of pre-defined model in clinical sub-groups of interest(12 months)
研究者
Hao Wen
Principal Investigator
Fudan University