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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple or multifocal primary lung cancer patients who underwent surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: San Valley Biotechnology Incorporated
• Investigators: Study Chair: Jun Wang, M.D., Peking University People's Hospital; Principal Investigator: Kezhong Chen, M.D., Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 9, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Circulating Tumor DNA; Heterogeneous; Multiple primary lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Lung Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: PTHO1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED