Identifying Genomic Mutations of Multiple Primary Lung Ca... | NCT02833467

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

NCT02833467

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Aug 28, 2019Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Carcinoma
Non-small-cell Lung Cancer
Thoracic Neoplasms

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2020Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Jul 9, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen KeZhong, MD，Thoracic Surgery Service, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Name	Class
San Valley Biotechnology Incorporated	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Multiple or multifocal primary lung cancer patients who underwent surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kezhong Chen, M.D.	Peking University People's Hospital	Principal Investigator
Jun Wang, M.D.	Peking University People's Hospital	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002277	Carcinoma
D002289	Carcinoma, Non-Small-Cell Lung
D013899	Thoracic Neoplasms

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D002283	Carcinoma, Bronchogenic

Browse Leaves

Not provided

Browse Branches

Not provided