Aromatase (CYP19) Polymorphism Between AI-responsive and... | NCT01137136

Studies
Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

NCT01137136

Sponsor

Samsung Medical Center

Status

Suspended

Last Update Posted

Apr 21, 2014Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Polymorphism
CYP19
Aromatase Inhibitor

Interventions

Not provided

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Because of economic issue, we could just enrolled total 150 patients.

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 2, 2010

First Submission Date that Met QC Criteria

Jun 3, 2010

First Posted Date

Jun 4, 2010Estimated

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

Apr 18, 2014

Last Update Posted Date

Apr 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor. However, the incidence of variation of CYP19 in Korea has not known. Therefore, the investigators want to know the incidence of variation of CYP19 and to assess the effect of these variations of CYP19 to aromatase inhibitor users.

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

Not provided

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SMAC (SMc AI user Cohort)		All patients who took the AI (Aromatase inhibitor)will be enrolled

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of CYP19 polymorphism		12. 31. 2011

Secondary Outcomes

Measure	Description	Time Frame
The effect of CYP19 polymorphism to the prognosis of AI user		12. 31. 2016

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hormone receptor positiveBreast cancer patient
postmenopausal women
first user of aromatase inhibitor

Exclusion Criteria:

premenopausal
The patient who take the other antihormonal therapy
osteoporosis patients

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Postmenopausa women who underwent surgery for breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seok Jin Nam, M.D., Ph.D.	Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Seoul	135-710	South Korea