CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI) (AI-CYP19)

September 8, 2009 updated by: Korea University Anam Hospital

Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 136-705
        • Recruiting
        • Korea University Anam Hopital
        • Contact:
        • Principal Investigator:
          • Eun Sook Lee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. The patient must sign the informed consent.
  2. The patient must sign the informed consent of genetic screening test.
  3. The patient must be between 18 years old and 80 years old who can make a decision independently.
  4. The patient must be post-menopause status.
  5. The patient should be the stage 1,2 or 3 of the breast cancer.
  6. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CYP19
CYP19 genetic polymorphism
Drug: Aromatase Inhibitor(Femara or Arimidex)
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Korea University

Investigators

  • Principal Investigator: Eun Sook Lee, MD, PhD, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2009

Last Update Submitted That Met QC Criteria

September 8, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN09021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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