Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-02 @ 12:53 PM
Study NCT ID:
NCT05406661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2022-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Local Recurrences After Breast-conserving Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain', 'timeFrame': '2 years', 'description': 'Number of cases per year'}, {'measure': 'Follow-up of recurrences up to 5 years after treatment of first recurrence', 'timeFrame': '5 years', 'description': 'Number of cases per year'}], 'secondaryOutcomes': [{'measure': 'Identification of risk factors for local recurrence', 'timeFrame': 'On inclusion time (2 years)', 'description': 'Frequency of risk factors'}, {'measure': 'Identification of predictive and response factors', 'timeFrame': 'On inclusion time (2 years)', 'description': 'Frequency of predictive factors'}, {'measure': 'Determination of surgical morbidity of relapse treatment in follow up', 'timeFrame': 'From date of treatment until 30 days after treatment', 'description': 'Identification of surgical morbidity'}, {'measure': 'Assessment of patient quality of life', 'timeFrame': 'First and second year after treatment', 'description': 'Validated questionnaire for quality of life by EORTC QLQ-C30-BR23'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer treatment', 'Local recurrences', 'Breast-conserving surgery'], 'conditions': ['Breast Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.\n\nThe comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with local recurrence after breast-conserving surgery', 'genderDescription': 'Female patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients\n2. Age \\> 18 years\n3. Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer\n\n 1. and adjuvant breast RT: total (WBI) or partial (PBI)\n 2. without adjuvant radiotherapy to the breast\n4. Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma\n\nExclusion Criteria:\n\n1. Male\n2. Age \\< 18 years\n3. Stage 4 at diagnosis\n4. Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment\n5. History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)\n6. Patients already treated for another local recurrence of breast carcinoma\n7. Absence of clinical follow-up and records in clinical process'}, 'identificationModule': {'nctId': 'NCT05406661', 'acronym': 'R_ReLoCC', 'briefTitle': 'Registry of Local Recurrences After Breast-conserving Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain', 'orgStudyIdInfo': {'id': 'R_ReLoCC'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Diana Gonçalves, MD, PhDc', 'role': 'CONTACT', 'email': 'diana.goncalves@chsj.min-saude.pt', 'phone': '(+351) 913017481'}, {'name': 'Janete Santos, PhD', 'role': 'CONTACT', 'email': 'investigaclinica@med.up.pt', 'phone': '(+351) 225 513 600'}], 'overallOfficials': [{'name': 'José Luis Fougo, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Mama - Centro Hospitalar Universitário de São João'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar Universitário São João, EPE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}