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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833467
First Posted: July 14, 2016
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
San Valley Biotechnology Incorporated
Information provided by (Responsible Party):
Chen KeZhong, Peking University People's Hospital
  Purpose
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

Condition
Carcinoma Non-small-cell Lung Cancer Thoracic Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA

Resource links provided by NLM:


Further study details as provided by Chen KeZhong, Peking University People's Hospital:

Primary Outcome Measures:
  • The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Fresh tumor tissue, peripheral blood cells, and plasma samples were collected from each patient.

Enrollment: 45
Study Start Date: January 2015
Estimated Study Completion Date: June 2021
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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 Oncomine Comprehensive Panel(OCP). High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple or multifocal primary lung cancer patients who underwent surgery
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833467


Sponsors and Collaborators
Peking University People's Hospital
San Valley Biotechnology Incorporated
Investigators
Principal Investigator: Kezhong Chen, M.D. Peking University People's Hospital
Study Chair: Jun Wang, M.D. Peking University People's Hospital
  More Information

Responsible Party: Chen KeZhong, MD,Thoracic Surgery Service, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02833467     History of Changes
Other Study ID Numbers: PTHO1502
First Submitted: July 9, 2016
First Posted: July 14, 2016
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chen KeZhong, Peking University People's Hospital:
Circulating Tumor DNA
Heterogeneous
Multiple primary lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms