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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Korea University Anam Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Korea University
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00973505
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Neoplasms
Arthralgia
Arthritis
Genetic Polymorphism
Drug: Aromatase Inhibitor(Femara or Arimidex)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CYP19
CYP19 genetic polymorphism
Drug: Aromatase Inhibitor(Femara or Arimidex)
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973505

Contacts
Contact: Eun Sook Lee, MD, PhD 82-2-920-6744 eslee@korea.ac.kr

Locations
Korea, Republic of
Korea University Anam Hopital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Eun Sook Lee, MD, PhD    82-2-920-6744    eslee@korea.ac.kr   
Principal Investigator: Eun Sook Lee, MD, PhD         
Sponsors and Collaborators
Korea University Anam Hospital
Korea University
Investigators
Principal Investigator: Eun Sook Lee, MD, PhD Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Eun Sook, Lee, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00973505     History of Changes
Other Study ID Numbers: AN09021
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Republic of Korea: Institutional Review Board

Keywords provided by Korea University Anam Hospital:
Breast neoplasms
Aromatase inhibitors
Genetic polymorphisms
Arthralgia
Arthritis

Additional relevant MeSH terms:
Arthralgia
Arthritis
Breast Neoplasms
Neoplasms
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Breast Diseases
Skin Diseases
Letrozole
Anastrozole
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 20, 2014