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临床试验/NCT04558255
NCT04558255Unknown不适用

Plasma Biomarkers as a Non-invasive Approach for Early Diagnosis of Lung Cancer

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Rates of malignant and benign pulmonary nodules measured by the postoperative pathology

研究概览

简要总结

Lung cancer is the most common cancer with the highest morbidity and mortality in the world. Stagement is closely related to the 5 years of survival rate of patients. The postoperative 5-year survival rate is above 90% for stage ⅠA lung cancer patients, while the 5-year survival rate of stage IV lung cancer patients is less than 5%. Therefore, early screening and diagnosis for lung cancer is a key method to reduce lung cancer mortality and prolong survival for patients.

At present, low-dose computed tomography (LDCT) is the most effective method for early detection of lung cancer. In addition to imaging examination, plasma tumor markers detection is also a common clinical detection method for tumor screening and postoperative monitoring.

Liquid biopsy is a non-invasive or minimally invasive method for testing blood or other liquid samples to analyze tumor-related markers including nucleic acids and proteins. Several studies have explored the detection of hot spot gene mutations, methylation and methylation changes of DNA, protein markers and autoantibodies in peripheral blood in lung cancer patients. Liquid biopsy has generally become the most popular field for early diagnosis of lung cancer.

Based above, it is necessary to combine multi-omics methods to improve the detection of early stage lung cancer. In our study, we intend to integrate molecular features obtained through liquid biopsy and clinical data of lung cancer patients, and develop and prospectively validate a machine-learning method which can robustly discriminate early-stage lung cancer patients from controls.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled patients are newly diagnosed patients
  • In patients diagnosed as pulmonary nodules by imaging, benign and malignant conditions of the nodules are determined by postoperative pathology after surgical resection
  • There is clear cancer stage information
  • In addition to pulmonary nodules, there are no suspicious nodules of other organs
  • No previous history of malignant tumor

排除标准

  • Patients with a history of malignant tumor
  • Patients with suspectednodules in other parts of the body at the time of diagnosis
  • Patients who have previously received surgery, chemotherapy or radiotherapy for pulmonary lesions
  • Patients with severe blood lipid in peripheral blood extracted which affects subsequent detection

结局指标

主要结局

Rates of malignant and benign pulmonary nodules measured by the postoperative pathology

时间窗: 5 days after the surgery

After the sugery of each patients with pulmonary nodules, we will get the clinicopathologic characteristics of the patients. Tumor stage and grade will be evaluated by us and rates of malignant and benign pulmonary nodules will be the primary outcome which we follow.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Wang

Director of the Thoracic Surgery Department

Peking University People's Hospital

研究点 (1)

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