Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA

• Conditions: Non-small-cell Lung Cancer; Thoracic Neoplasms; Carcinoma

• Registration Number: NCT02833467
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients

Detailed Description

Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-07-09
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-01
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients must have given written informed consent
• Histopathologically confirmed NSCLC
• Considered multiple or multifocal primary lung cancer by clinical criteria

Exclusion Criteria

• Malignant tumor history within the past 5 years
• Patients who received any treatment prior to resection
• Insufficient tumor tissue or blood sample

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing	18 months

Secondary Outcome Measures

Name	Time	Method
The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients	18 months
The relationship between overall survival and genomic results in multiple primary lung cancer patients	5 years
The relationship between disease free survival and genomic results in multiple primary lung cancer patients	5 years