Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00973505
Status:
UNKNOWN
Last Update Posted:
2009-09-09
First Post:
2009-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-08', 'studyFirstSubmitDate': '2009-09-08', 'studyFirstSubmitQcDate': '2009-09-08', 'lastUpdatePostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level', 'timeFrame': '6, 12 months'}], 'secondaryOutcomes': [{'measure': 'EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI', 'timeFrame': '3,6,12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast neoplasms', 'Aromatase inhibitors', 'Genetic polymorphisms', 'Arthralgia', 'Arthritis'], 'conditions': ['Breast Neoplasms', 'Arthralgia', 'Arthritis', 'Genetic Polymorphism']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients taking the medication of AI (aromatase inhibitor) in post menopause status.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient must sign the informed consent.\n2. The patient must sign the informed consent of genetic screening test.\n3. The patient must be between 18 years old and 80 years old who can make a decision independently.\n4. The patient must be post-menopause status.\n5. The patient should be the stage 1,2 or 3 of the breast cancer.\n6. The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).\n\nExclusion Criteria:\n\n1. The patient is pre-menopause status.\n2. The test result of serum FSH level is below 30mU/ml.\n3. The test result of the hormone receptor(ER \\& PR) is negative or unknown.\n4. Patient's breast cancer stage is 4 which has systemic metastatics."}, 'identificationModule': {'nctId': 'NCT00973505', 'acronym': 'AI-CYP19', 'briefTitle': 'CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)', 'orgStudyIdInfo': {'id': 'AN09021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CYP19', 'description': 'CYP19 genetic polymorphism', 'interventionNames': ['Drug: Aromatase Inhibitor(Femara or Arimidex)']}], 'interventions': [{'name': 'Aromatase Inhibitor(Femara or Arimidex)', 'type': 'DRUG', 'description': 'Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd', 'armGroupLabels': ['CYP19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Sook Lee, MD, PhD', 'role': 'CONTACT', 'email': 'eslee@korea.ac.kr', 'phone': '82-2-920-6744'}, {'name': 'Eun Sook Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Anam Hopital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Eun Sook Lee, MD, PhD', 'role': 'CONTACT', 'email': 'eslee@korea.ac.kr', 'phone': '82-2-920-6744'}], 'overallOfficials': [{'name': 'Eun Sook Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Eun Sook, Lee', 'oldOrganization': 'Korea University Anam Hospital'}}}}