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

A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02645318

Enrollment

Registered

2016-01-01

Start date

2015-05-31

Completion date

2015-07-31

Last updated

2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Circulating Tumor DNA, Lung cancer, Targeted sequencing

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer	2-3months
Correlation of ctDNA concentration with clinical features	2-3months
Comparison of positive predictive value between ctDNA and tumor markers	2-3months
The relationship between ctDNA concentration and disease free survival(DFS）	3 years

Countries

China

Outcome results