Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)

Breast Cancer Clinical Trial

— IRONY  

Official title:

IRONY: lIfe afteR ONcoplastic surgerY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842148
• Other study ID #: PAR 13.23 OSS
• Status: Recruiting
• Start date: March 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Campus Bio-Medico University
• Contact: Paolo Orsaria, MD, PhD
• Phone: 3282492485
• Email: p.orsaria[@]policlinicocampus.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer

Description:

The aim of the study is the evaluation of the oncological, aesthetic and functional results after conservative oncoplastic breast surgery using unilateral or bilateral remodeling techniques in a prospective sample of 250 patients. Endpoints: - evaluation of post-surgical histopathological data with a selective focus on the achievement of oncological radicality in relation to the surgical technique ( resection volume, locoregional extension / TNM / multifocality and tumor biological profile) and any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).This data will be collected through the compilation of a database by the health personnel. - evaluation of aesthetic and functional results related to the quality of life after oncoplastic conservative surgery (unilateral or bilateral), as data perceived by the surgeon (technical analysis), and by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy). This data will be collected through the administration of a questionnaire whose data will be entered into the database by the healthcare personnel.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of breast cancer
• Must be able for conservative oncoplastic surgery with type 1 and 2 procedures who give informed consent to the study.

Exclusion Criteria:

• Patients who are pregnant or breastfeeding
• Patients in emergency situations
• Subjects unable to understand and want

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).
• Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
Control and review of post-surgical complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).
• Study and recording of aesthetic and functional post-surgical results related to the quality of life, as data perceived by the surgeon (technical analysis), and by the patient.
Control and review of technical analysis by the surgeon, and of psychosocial well-being, physical discomfort, adverse effects of radiotherapy by the patient collected through the administration of a questionnaire.

Locations

Country	Name	City	State
Italy	Paolo Orsaria, MD. PhD; [porsaria]	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Cali Cassi L, Vanni G, Petrella G, Orsaria P, Pistolese C, Lo Russo G, Innocenti M, Buonomo O. Comparative study of oncoplastic versus non-oncoplastic breast conserving surgery in a group of 211 breast cancer patients. Eur Rev Med Pharmacol Sci. 2016 Jul;20(14):2950-4. — View Citation

Orsaria P, Grasso A, Caggiati L, Altomare M, Altomare V. Update on oncoplastic techniques in breast conserving surgery: algorithms for predictable results and custom-made reconstructions. Minerva Surg. 2021 Dec;76(6):512-525. doi: 10.23736/S2724-5691.21.08976-0. Epub 2021 Aug 2. — View Citation

Orsaria P, Grasso A, Ippolito E, Pantano F, Sammarra M, Altomare C, Cagli B, Costa F, Perrone G, Soponaru G, Caggiati L, Vanni G, Buonomo OC, Altomare V. Clinical Outcomes Among Major Breast Cancer Subtypes After Neoadjuvant Chemotherapy: Impact on Breast Cancer Recurrence and Survival. Anticancer Res. 2021 May;41(5):2697-2709. doi: 10.21873/anticanres.15051. — View Citation

Orsaria P, Grasso A, Soponaru G, Carnevale F, Scorsone V, Ippolito E, Pantano F, Sammarra M, Piccolo C, Altomare M, Perrone G, Altomare V. Subaxillary Replacement Flap Compared with the Round Block Displacement Technique in Oncoplastic Breast Conserving Surgery: Functional Outcomes of a Feasible One Stage Reconstruction. Curr Oncol. 2022 Nov 30;29(12):9377-9390. doi: 10.3390/curroncol29120736. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of post-surgical data	focus on the achievement of oncological radicality in relation to the surgical technique (yes or no).	three years
Primary	evaluation of resection volumes	focus on the resection volume in relation to the surgical technique (cm3).	three years
Primary	evaluation of post-surgical staging criteria	focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition)	three years
Primary	evaluation of multifocality	focus on the multifocality (yes or no).	three years
Primary	evaluation of tumor biological profile	focus on the tumor biological profile ( luminal A, luminal B HER2-, luminal B HER2+, HER2+, triple-negative).	three years
Primary	evaluation of any post-surgical associated complications	focus on any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).	three years
Secondary	evaluation of post-surgical aesthetic results	focus on data perceived by the surgeon (technical analysis) through a questionnaire with scores ranging from 1 to 3.	three years
Secondary	evaluation of post-surgical functional results related to the quality of life after oncoplastic conservative surgery (unilateral or bilateral) through a questionnaire with scores ranging from 1 to 3.	focus on data perceived by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy).	three years