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

Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02833467
• Other study ID #: PTHO1502
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: June 2021

Study information

• Verified date: August 2019
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: June 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lung Neoplasms
• Non-small-cell Lung Cancer
• Thoracic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	San Valley Biotechnology Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing		18 months
Secondary	The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients		18 months
Secondary	The relationship between disease free survival and genomic results in multiple primary lung cancer patients		5 years
Secondary	The relationship between overall survival and genomic results in multiple primary lung cancer patients		5 years