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A Preliminary Study on the Detection of Plasma Markers in Early Diagnosis for Lung Cancer

2020年9月21日 更新者:Jun Wang、Peking University People's Hospital

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

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.

研究概览

研究类型

观察性的

注册 (预期的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing、Beijing、中国、100044
        • 招聘中
        • Peking University People's Hospital
        • 接触:
          • Chen Kezhong, M.D.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

500 cases will be enrolled including 100 cases of benign pulmonary nodules, 300 cases of stage I and II lung cancer, 100 cases of stage III lung cancer. All enrolled patients are newly diagnosed as pulmonary nodules by imaging, benign and malignant conditions of the nodules are determined by postoperative pathology after surgical resection. All clinacal data including cancer stage information are available.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Rates of malignant and benign pulmonary nodules measured by the postoperative pathology
大体时间: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.
5 days after the surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Jun Wang, M.D.、Peking University People's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月1日

初级完成 (预期的)

2020年12月1日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2020年9月13日

首先提交符合 QC 标准的

2020年9月21日

首次发布 (实际的)

2020年9月22日

研究记录更新

最后更新发布 (实际的)

2020年9月22日

上次提交的符合 QC 标准的更新

2020年9月21日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • PTHO1903

药物和器械信息、研究文件

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