NCT04817046招募中不适用
Detection of Early-stage Lung Cancer Based on Liquid Biopsy of Peripheral Blood: a Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Accuracy of the multi-omics early-stage lung cancer diagnosis model
研究概览
简要总结
The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening process to determine eligibility of study entry. Peripheral blood, tissue sample and imaging examinations of eligible patients will be collected for further analysis. Data collected will be used to develop a multi-omics lung cancer diagnosis model.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male or female, age equal to or greater than 40 years old and less than 75 years old
- •Blood sample was collected before surgery for the detection of cfDNA methylation and other biomarkers
- •Lung cancer patients diagnosed for the first time within 42 days before blood sampling without any anti-tumor treatment; or patients who are highly suspected of lung cancer through imaging evaluation or other routine clinical diagnosis and confirmed by tissue biopsy or surgical specimens within 42 days after blood sampling
- •The subject has not received any local or systemic anti-tumor therapy before blood collection, including (not limited to) any surgery, local or systemic radiotherapy and chemotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines and hormone therapy, etc.
排除标准
- •Unable to obtain sufficient and qualified blood samples
- •Female subjects who are pregnant or breastfeeding
- •Patients who have received organ transplantation or non-autologous bone marrow or stem cell transplantation
- •Patients who have received blood transfusion within 7 days before blood sampling
- •Patients who have received anti-infection treatment within 14 days before blood collection
- •Patients who have receiving anti-tumor drugs for other diseases within 30 days before blood collection, such as methotrexate, cyclophosphamide, mercaptopurine, chlorambucil, tamoxifen, etc.
- •Patients who suffered from other malignant tumors or multiple primary tumors at the same time
- •Pathological confirmed benign lesions by tissue biopsy or surgery
- •Insufficient sample for a confirmed pathological diagnosis
- •Lung cancer patients with ground glass nodules on CT imaging.
结局指标
主要结局
Accuracy of the multi-omics early-stage lung cancer diagnosis model
时间窗: through study completion, an average of 1.5 year
Sensitivity and specificity of the multi-omics early-stage lung cancer diagnosis model
次要结局
- Accuracy of diagnostic models established separately from multi-omics data(through study completion, an average of 1.5 year)
- Relationship between multi-omics data(through study completion, an average of 1.5 year)
研究者
Jun Wang
Professor
Peking University People's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Biomarkers for Diagnosis of Lung CancerLung CancerLung NeoplasmNCT02050100SK Medical (Beijing) Co., Ltd.300
Unknown
不适用
'Lung Health Check' Biomarker StudyCancerLung CancerNCT04957433Royal Marsden NHS Foundation Trust1,000
尚未招募
不适用
Understanding Lung Cancer Related Risk Factors and Their ImpactLung Cancer ScreeningNCT06473870Biocruces Bizkaia Health Research Institute6,160
终止
不适用
Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) NetworkNon-small Cell Lung Cancer MetastaticSmall Cell Lung CarcinomaNCT01574300Addario Lung Cancer Medical Institute136
尚未招募
不适用
Early Detection of Lung Cancer With Machine Learning Based on Routine Clinical InvestigationsAdenocarcinoma of Lung; Bronchial Neoplasms; Early Detection of Cancer; Machine LearningNCT05907577The University Clinic of Pulmonary and Allergic Diseases Golnik7,500