Comparison of Genomic and Transcriptomic Patterns Between... | NCT04932343

Studies
Comparison of Genomic and Transcriptomic Patterns Between CTC and Metastatic Tumormetastatic Tumor

NCT04932343

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jun 21, 2021Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

NSCLC Stage IV
NSCLC Stage IIIB

Interventions

cohort study

Countries

South Korea

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

Official Title

Comparison of Genomic and Transcriptomic Patterns Between the Circulating Tumor Cells and Metastatic Tumor Cells, and Their Specific Relevance to Circulating Tumor DNAs: Quest for Any Distinct or Complementary Roles of CTCs and ctDNAs to Understand the Metastasis in Advanced NSCLC

Status Module

Record Verification Date

Jun 2021

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

Jun 1, 2021Actual

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jun 13, 2021

First Submission Date that Met QC Criteria

Jun 18, 2021

First Posted Date

Jun 21, 2021Actual

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

Jun 18, 2021

Last Update Posted Date

Jun 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jhingook Kim, MD, Professor, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Name	Class
CytoGen, Inc.	INDUSTRY
UNIST (Ulsan National Institute of Science and Technology)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
cohort study	Diagnostic Test	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The gene expression and the cell population	Methods for the single cell RNA sequencing and whole exome sequencing of the tumor cells With the tissue biopsied specimens, scRNAseq (by 10X Genomics platform) and whole exome seq will be carried out.	3 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects need to sign the informed consent form
All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively
Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV)
Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing

Exclusion Criteria:

Patients with previous history of lung cancer
Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Treatment naïve stage III-IV non-small cell lung cancer who undergoing surgery for any intent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jhingook Kim, MD	Samsung Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		06351	South Korea

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
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided