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

Shandong First Medical University

Status: Not yet enrolling

Conditions: Breast Cancer Female; Oncological Safety; Patient Reported Outcome; Breast-conserving Surgery

Treatments: Procedure: conventional breast-conserving surgery; Procedure: oncoplastic breast-conserving surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05054777

ShandongCHI-18

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent signed;
2. Non-metastatic Breast cancer patients confirmed by pathology;
3. Adult (>18 years old, <80 years old);
4. Female;
5. Must undergo oncoplastic or conventional breast-conserving surgery;

Exclusion criteria

1. Inflammatory breast cancer, Stage IV breast cancer patients;
2. Have other malignant tumors;
3. Pregnancy women;
4. Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients;
5. Refuse breast-conserving surgery.

Trial design

5,000 participants in 2 patient groups

oncoplastic breast-conserving surgery

Description:

The oncoplastic breast-conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques

Treatment:

Procedure: oncoplastic breast-conserving surgery

conventional breast-conserving surgery

Description:

The conventional breast-conserving surgery were performed without any oncoplastic operations

Treatment:

Procedure: conventional breast-conserving surgery