Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 12:24 AM
Study NCT ID:
NCT05213403
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of a new scoring system', 'timeFrame': '2016-2021', 'description': 'Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients'}], 'secondaryOutcomes': [{'measure': 'Evaluation of outcome disease', 'timeFrame': '2016-2021', 'description': 'Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Our aim is to create a Scoring System (SS) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing NACT.\n\nSecondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating:\n\n* Loco-regional disease free-survival (LR-DFS): months between start of NACT and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla.\n* Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases.\n* Overall survival (OS): months from the start of NACT to death or last follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing neoadjuvant chemotherapy subsequently subjected to conservative surgery (Quadrantectomy/lumpectomy), Oncoplastic surgery second level or conservative mastectomy with breast reconstruction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing neoadjuvant chemotherapy\n* Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)\n\nExclusion Criteria:\n\n* lack of initial staging or restaging;\n* previous or synchronous history of systemic malignant neoplasms.\n* history of homo-or contralateral breast cancer.\n* initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV)\n* indication to modified radical mastectomy (MRM) without delayed reconstruction'}, 'identificationModule': {'nctId': 'NCT05213403', 'acronym': 'BreastNESSy', 'briefTitle': 'Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': '4694'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient G1', 'description': 'Correlation between surgery and scoring system', 'interventionNames': ['Diagnostic Test: Evaluation with new scoring system']}, {'label': 'Patients G2', 'description': 'Incongruence between surgery and scoring system', 'interventionNames': ['Diagnostic Test: Evaluation with new scoring system']}], 'interventions': [{'name': 'Evaluation with new scoring system', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes', 'armGroupLabels': ['Patient G1', 'Patients G2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gianluca Franceschini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Policlinico Agostino Gemelli - Roma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.ssa', 'investigatorFullName': 'FABI ALESSANDRA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}