Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

NCT05213403 | Completed

• 1 other identifier: 4694
• Study Type: observational
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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.

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Development of a new scoring system

  Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients

  2016-2021

Secondary Outcomes (1)

• Evaluation of outcome disease

  2016-2021

Study Arms (2)

Patient G1

Correlation between surgery and scoring system

Diagnostic Test: Evaluation with new scoring system

Patients G2

Incongruence between surgery and scoring system

Diagnostic Test: Evaluation with new scoring system

Interventions

Evaluation with new scoring system DIAGNOSTIC_TEST

Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes

Patient G1; Patients G2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing neoadjuvant chemotherapy subsequently subjected to conservative surgery (Quadrantectomy/lumpectomy), Oncoplastic surgery second level or conservative mastectomy with breast reconstruction

You may qualify if:

• Patients undergoing neoadjuvant chemotherapy
• Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)

You may not qualify if:

• lack of initial staging or restaging;
• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gianluca Franceschini, Prof.

  IRCCS Policlinico Agostino Gemelli - Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.ssa

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 28, 2022
• Study Start: January 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01