A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-center, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14,300
- 试验地点
- 7
- 主要终点
- The performance of mult-modal in lung cancer early detection
研究概览
简要总结
This study is a multi-center, observational study aiming to develop an early screening multi-model for detecting lung cancer signals through the integration of imaging (non-contrast CT) and blood testing (cfDNA methylation).
详细描述
This study aims to develop three modality -based models for lung cancer early screening, incuding a CT-based imaging model, a blood-based cfDNA methylation model, and a multimodal framework. First, 10,700 retrospective non-contrast CT scans will be collected to construct the CT imaging-based model. This model will extract multi- scale structural features through a hierarchical modeling framework, enabling the learning of interpretable spatial representations. Second, cfDNA methylation data from lung cancer patients and healthy individuals enrolled in the ProFound study (NCT06217900) wll be used to develop the blood-based model. Third, subjects with paired CT imaging and cfDNA methylation data from the ProFound study will be included to construct a multimodal model by integrating information across modalities. The performance of models based on different modalities will be systematically compared to evaluate their respective and complementary contributions to lung cancer early screening.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-74 years old
- •Clinically and/or pathologically diagnosed 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 ≥ 38.5 °C) within 14 days prior to screen
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 30 days prior to screen
- •Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
- •Unsuitable for this trial determined by the researchers
- •Low-quality samples: images only partially showing the lungs or in lateral decubitus position, unreadable due to severe motion artifacts/metal artifacts, or with missing critical metadata
- •Inclusion Criteria for Control Arm Participants:
- •40-74 years old
- •Without confirmed cancer diagnosis
- •Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- •Exclusion Criteria for Control Arm Participants:
- •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 ≥ 38.5 °C) within 14 days prior to screen
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 30 days prior to screen
- •Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
- •Unsuitable for this trial determined by the researchers
- •Low-quality samples: images only partially showing the lungs or in lateral decubitus position, unreadable due to severe motion artifacts/metal artifacts, or with missing critical metadata
研究组 & 干预措施
CT cohort
Lung cancer patients or healthy individuals who can provide CT scan
Multi-modal cohort
Retrospective collect paired CT and blood based cfDNA methylation information from Profound study
Blood-based cohort
Blood based cfDNA methylation information retrieved from Profound study
结局指标
主要结局
The performance of mult-modal in lung cancer early detection
时间窗: 12 months
The sensitivity, specificity and AUC for lung cancer early detection in detecting cancer or non-cancer at 95% confidence interval
次要结局
- The performance of multi-modal across subgroup analysis(12 months)
- Comparing the performance of three different modals.(12 months)
研究者
Chang Chen
Chief Physician
Shanghai Pulmonary Hospital, Shanghai, China