A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Peking University People's Hospital
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.
Detailed Description
Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC. We plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient who is confirmed primary lung cancer by frozen pathologic histology
- •Both the fresh tissue tumor and plasma samples are collected for analysis
Exclusion Criteria
- •Patients who received any treatment prior to resection
- •Patients who have a history of malignancy
- •Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma
- •Tumor specimens where insufficient DNA
Outcomes
Primary Outcomes
Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample
Time Frame: 2-3 months
Secondary Outcomes
- Comparison of positive predictive value between ctDNA and tumor markers(2-3months)
- Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer(2-3months)
- The relationship between ctDNA concentration and disease free survival(DFS）(3 years)
- Correlation of ctDNA concentration with clinical features(2-3months)