Genetic Characteristics of Metastatic Breast Cancer Patients | NCT04258735

Studies
Genetic Characteristics of Metastatic Breast Cancer Patients

NCT04258735

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Feb 6, 2020Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Metastatic Breast Cancer

Interventions

Genomic analysis

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

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2019Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Jul 31, 2024Estimated

First Submitted Date

Jul 23, 2019

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 6, 2020Actual

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

Feb 5, 2020

Last Update Posted Date

Feb 6, 2020Actual

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

Genomic analysis for metastatic breast cancer(MBC) patients

Participant (Inclusion criteria)
1. Patients who diagnosed metastatic/stage IV breast cancer
2. Patients who were not received treatment for metastatic breast cancer on palliative setting
Process

(1) Tissue/ Blood sample
At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional)

(2) WES, RNASeq, ctDNA, Exosome
We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metastatic breast cancer cohort	Other	Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome	Diagnostic Test: Genomic analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genomic analysis	Diagnostic Test	WES, RNASeq, ctDNA, Exosome	Metastatic breast cancer cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genomic profiling of MBC patients	Gemetic alteration frequency, the association between genetic alteration and survival	60 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who diagnosed ad metastatic breast cancer
Patients who were not received treatment on palliative setting

Exclusion Criteria:

Patients who did not agree this study
Patients who did not have any pathologic specimen at MBC diagnosis.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Young-Hyuck Im, MD,PhD	Contact	82-2-3410-3459		yh00.im@samsung.com
Ji-Yeon Kim, MD	Contact	82-2-3410-3459		jyeon25.kim@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center, Sungkyunkwan University School of Medicine	Recruiting	Seoul		135-710	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
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided