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

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ClinicalTrials.gov Identifier: NCT00973505
Recruitment Status : Unknown
Verified September 2009 by Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Sponsor:
Collaborator:
Korea University
Information provided by:
Korea University Anam Hospital

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.

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

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)
Study Start Date : March 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level [ Time Frame: 6, 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eun Sook, Lee, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00973505     History of Changes
Other Study ID Numbers: AN09021
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009

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

Additional relevant MeSH terms:
Arthritis
Breast Neoplasms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aromatase Inhibitors
Anastrozole
Letrozole
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents