Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-25 @ 8:15 AM
Study NCT ID:
NCT02791750
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2016-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma
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': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-06-03', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors associated with persistence to hormone therapy for breast cancer', 'timeFrame': '1 day', 'description': "Women will be classed as persistent if they don't discontinue or abandon hormone therapy during the 5 years after the introduction of the medication. The information will be recorded thanks to a self-questionnary fulfilled the inclusion day.\n\nThe baseline characteristics will be compared between persistent women and non-persistent women."}], 'secondaryOutcomes': [{'measure': 'Comparison of the quality of life', 'timeFrame': '1 day', 'description': 'Quality of life between patients who continued hormone therapy for 5 years and patients who discontinued treatment early will be searched for using the questionnaire'}, {'measure': 'Proportion of women with a change in their treatment', 'timeFrame': '1 day', 'description': 'Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.'}, {'measure': 'Cause of treatment discontinuation', 'timeFrame': '1 day', 'description': 'In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.'}, {'measure': 'Continued homonotherapy', 'timeFrame': '1 day', 'description': 'In the subgroup of women who have been treated with hormone therapy for 5 years, determine the proportion of women not opposed to the continuation of hormone therapy beyond 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hormone replacement therapy', 'breast cancer', 'follow up'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy\n* Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy\n* Adult patients\n* Being capable and agree to follow the study procedure\n* Patients informed and non-opposed\n* Covered by social security\n\nExclusion Criteria:\n\n* History of other cancer except basal cell carcinoma\n* Patients with breast invasive carcinoma negative-RH\n* Synchronous metastases\n* Relapsed\n* Previous adjuvant hormonal therapy\n* Men\n* Patients with guardianship'}, 'identificationModule': {'nctId': 'NCT02791750', 'acronym': 'HACAMI', 'briefTitle': '5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': '5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma', 'orgStudyIdInfo': {'id': 'ICL OBS 02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients followed for a medical consultation in the Institut de Cancérologie de Lorraine at 5 years of the beginning of an adjuvant hormonal therapy.', 'interventionNames': ['Other: questionnary of quality of life']}], 'interventions': [{'name': 'questionnary of quality of life', 'type': 'OTHER', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'LESUR ANNE, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}