Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 7:10 PM
Study NCT ID:
NCT00814034
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2008-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-04', 'studyFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change (%) from baseline of the blood coagulation parameters (fibrinogen, PT, aPTT) at 6, 12, 18, and 24 months of treatment.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aromatase Inhibitors', 'Coagulation parameters', 'Tamoxifen'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to monitor the changes of blood coagulation parameters in postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5 years. The values of the standard coagulation parameters throughout the study will be compared with the baseline values.', 'detailedDescription': 'Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons. The choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy. Percentage change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of treatment. The blood coagulation parameters which will be measured are fibrinogen, prothrombin time (PT) and activated partial thromboplastin time (aPTT).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal, ER and/or PgR positive breast cancer patients eligible for adjuvant hormonal treatment (HT), who are admitted for treatment and follow-up at the participating sites, will be enrolled in the trial. Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons.\n\nThe choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal status. ER and/or PgR status positive. Adjuvant hormonal treatment for 5 years according to standard practice has been decided by the treating physician. Values within normal limits for the blood coagulation parameters at baseline visit. Accessible for follow-up for the duration of the trial. Written informed consent.\n\nExclusion Criteria:\n\n* Both ER and PgR negative primary tumor. Evidence of distant metastases (M1) Neo-adjuvant hormonotherapy. Chronic use of oral anticoagulants such as warfarin or acenocoumarol. Psychiatric disorders preventing proper informed consent. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.'}, 'identificationModule': {'nctId': 'NCT00814034', 'acronym': 'COPA', 'briefTitle': 'Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Breast Surgeons Society'}, 'officialTitle': 'An Observational, Prospective Cohort Study, on Blood Coagulation Parameters in Postmenopausal Patients With Operable Breast Cancer Who Are Treated as Per Standard Practice With Adjuvant Hormonal Therapy for a Total of 5 Years', 'orgStudyIdInfo': {'id': 'COPA-HBSS0801'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1:Tamoxifen'}, {'label': '2:Steroidal Aromatase Inhibitor'}, {'label': '3:Non-steroidal Aromatase Inhibitor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11523', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Hellenic Breast Surgeons Society', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Hellenic Breast Surgeons Society', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Christos Markopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hellenic Breast Surgeons Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Breast Surgeons Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery, Athens University Medical School', 'investigatorFullName': 'Markopoulos Christos', 'investigatorAffiliation': 'Hellenic Breast Surgeons Society'}}}}