This trial is active, not recruiting.

Conditions carcinoma, non-small-cell lung cancer, thoracic neoplasms
Sponsor Peking University People's Hospital
Collaborator San Valley Biotechnology Incorporated
Start date January 2015
End date June 2016
Trial size 45 participants
Trial identifier NCT02833467, PTHO1502


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

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
time frame: 18 months
The relationship between disease free survival and genomic results in multiple primary lung cancer patients
time frame: 5 years
The relationship between overall survival and genomic results in multiple primary lung cancer patients
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
Principal investigator Kezhong Chen, M.D.
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 Oncomine Comprehensive Panel(OCP). High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Peking University People's Hospital.