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

NCT ID: NCT02833467

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma Non-small-cell Lung Cancer Thoracic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

San Valley Biotechnology Incorporated

UNKNOWN

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chen KeZhong

MD,Thoracic Surgery Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kezhong Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Jun Wang, M.D.

Role: STUDY_CHAIR

Peking University People's Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PTHO1502

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.