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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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oncoplastic breast-conserving surgery

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

oncoplastic breast-conserving surgery

Intervention Type PROCEDURE

The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques

conventional breast-conserving surgery

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

conventional breast-conserving surgery

Intervention Type PROCEDURE

conventional breast-conserving surgery without any oncoplastic operations

Interventions

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oncoplastic breast-conserving surgery

The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques

Intervention Type PROCEDURE

conventional breast-conserving surgery

conventional breast-conserving surgery without any oncoplastic operations

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No