NCT05054777

Patient Report Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort

Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic BCS could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as conventional BCS does. However, these studies that focused on patient-reported outcomes and oncological safety were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome (PROs) and oncological safety will be planned to assess the PROs and safety for Chinese breast cancer patients who will undergo oncoplastic and conventional breast-conserving surgery (OBCS). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to sign the informed consent and will be followed up 24 months after operations. All data will be collected.

Conditions

• Patient Reported Outcome
• Oncological Safety
• Breast-conserving Surgery
• Breast Cancer Female

Interventions

Type	Name	Description
PROCEDURE	oncoplastic breast-conserving surgery	The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques
PROCEDURE	conventional breast-conserving surgery	conventional breast-conserving surgery without any oncoplastic operations

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2021-09-23
• Last updated: 2021-09-23