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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02833467

Enrollment

Registered

2016-07-14

Start date

2015-01-31

Completion date

2021-06-30

Last updated

2019-08-28

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 Cancer, Thoracic Neoplasms

Keywords

Circulating Tumor DNA, Heterogeneous, Multiple primary lung cancer

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 disease free survival and genomic results in multiple primary lung cancer patients	5 years
The relationship between overall survival and genomic results in multiple primary lung cancer patients	5 years

Outcome results