CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI) | NCT00973505

Studies
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

NCT00973505

Sponsor

Korea University Anam Hospital

Status

Unknown status

Last Update Posted

Sep 9, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Breast Neoplasms
Arthralgia
Arthritis
Genetic Polymorphism

Interventions

Aromatase Inhibitor(Femara or Arimidex)

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

Sep 2009

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

Mar 2009

Primary Completion Date

Sep 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

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

Sep 8, 2009

Last Update Posted Date

Sep 9, 2009Estimated

Name	Class
Korea University	OTHER

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

The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYP19		CYP19 genetic polymorphism	Drug: Aromatase Inhibitor(Femara or Arimidex)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aromatase Inhibitor(Femara or Arimidex)	Drug	Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd	CYP19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level		6, 12 months

Secondary Outcomes

Measure	Description	Time Frame
EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI		3,6,12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient must sign the informed consent.
The patient must sign the informed consent of genetic screening test.
The patient must be between 18 years old and 80 years old who can make a decision independently.
The patient must be post-menopause status.
The patient should be the stage 1,2 or 3 of the breast cancer.
The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).

Exclusion Criteria:

The patient is pre-menopause status.
The test result of serum FSH level is below 30mU/ml.
The test result of the hormone receptor(ER & PR) is negative or unknown.
Patient's breast cancer stage is 4 which has systemic metastatics.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients taking the medication of AI (aromatase inhibitor) in post menopause status.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eun Sook Lee, MD, PhD	Contact	82-2-920-6744		eslee@korea.ac.kr

Overall Officials

Name	Affiliation	Role
Eun Sook Lee, MD, PhD	Korea University Anam Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Anam Hopital	Recruiting	Seoul		136-705	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D018771	Arthralgia
D001168	Arthritis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077384	Anastrozole

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided