CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

NCT00973505 | Unknown

• 1 other identifier: AN09021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Arthralgia; Arthritis; Genetic Polymorphism

Keywords

Breast neoplasms; Aromatase inhibitors; Genetic polymorphisms; Arthralgia; Arthritis

Outcome Measures

Primary Outcomes (1)

• Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level

  6, 12 months

Secondary Outcomes (1)

• EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI

  3,6,12 months

Study Arms (1)

CYP19

CYP19 genetic polymorphism

Drug: Aromatase Inhibitor(Femara or Arimidex)

Interventions

Aromatase Inhibitor(Femara or Arimidex) DRUG

Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

CYP19

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Korea University: collaborator

Study Sites (1)

Korea University Anam Hopital

Seoul, 136-705, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia; Arthritis

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eun Sook Lee, MD, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Sook Lee, MD, PhD

CONTACT

82-2-920-6744; eslee@korea.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 9, 2009

Record last verified: 2009-09

Locations

KR (1)