NCT01137136

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

4.5 years

First QC Date

June 2, 2010

Last Update Submit

April 18, 2014

Conditions

PolymorphismCYP19Aromatase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • The prevalence of CYP19 polymorphism

    12. 31. 2011

Secondary Outcomes (1)

  • The effect of CYP19 polymorphism to the prognosis of AI user

    12. 31. 2016

Study Arms (1)

SMAC (SMc AI user Cohort)

All patients who took the AI (Aromatase inhibitor)will be enrolled

Eligibility Criteria

AgeUp to 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausa women who underwent surgery for breast cancer

You may qualify if:

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

You may not qualify if:

  • premenopausal
  • The patient who take the other antihormonal therapy
  • osteoporosis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Study Officials

  • Seok Jin Nam, M.D., Ph.D.

    Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D., Ph.D.

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 4, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

KR(1)