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Clinical Trials/NCT02833467
NCT02833467
Unknown
Not Applicable

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

Peking University People's Hospital0 sites45 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carcinoma
Sponsor
Peking University People's Hospital
Enrollment
45
Primary Endpoint
The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chen KeZhong

MD,Thoracic Surgery Service

Peking University People's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing

Time Frame: 18 months

Secondary Outcomes

  • 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)

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