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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.

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Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes