Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02645318
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Study First Posted: 2016-01-01
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample	2-3 months

Secondary Outcome Measures

Name	Time	Method
Correlation of ctDNA concentration with clinical features	2-3months
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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China