The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma
- Sponsor
- Peking University People's Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer
- Last Updated
- 6 years ago
Overview
Brief Summary
Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients
Detailed Description
Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying. Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.
Investigators
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •Sign informed consent and consent to participate in this study;
- •Found small nodules in pulmonary by CT and prepare for surgery;
Exclusion Criteria
- •Malignant tumor history within the past 5 years;
- •Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
- •No matching tissue or blood samplesUnqualified blood samples
- •Lesion is pure ground glass opacity.
Outcomes
Primary Outcomes
The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer
Time Frame: 12 months
Secondary Outcomes
- Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer(12 months)
- The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection(36 months)
- Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches(36 months)