Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy
NCT ID: NCT05213403
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2016-01-01
2021-12-31
Brief Summary
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Secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating:
* 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.
* Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases.
* Overall survival (OS): months from the start of NACT to death or last follow-up.
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Patient G1
Correlation between surgery and scoring system
Evaluation with new scoring system
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes
Patients G2
Incongruence between surgery and scoring system
Evaluation with new scoring system
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes
Interventions
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Evaluation with new scoring system
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes
Eligibility Criteria
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Inclusion Criteria
* Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)
Exclusion Criteria
* previous or synchronous history of systemic malignant neoplasms.
* history of homo-or contralateral breast cancer.
* initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV)
* indication to modified radical mastectomy (MRM) without delayed reconstruction
18 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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FABI ALESSANDRA
Dr.ssa
Principal Investigators
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Gianluca Franceschini, Prof.
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico Agostino Gemelli - Roma
Other Identifiers
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4694
Identifier Type: -
Identifier Source: org_study_id
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