Patient Report Outcome-Reconstruction and Oncoplastic Cohort

Summary

Available studies that focused on patient-reported outcomes (PROs) 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-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs for Chinese breast cancer patients who will undergo breast reconstruction or oncoplastic breast-conserving surgery (OBCS). The inclusion criteria are female breast cancer patients \>18 years old, who will undergo breast reconstruction (BR) or OBCS. This cohort will include at least 10000 patients (about 5000 patients who undergo BR, and 5000 patients who undergo OBCS). The exposures were the surgery types: BR and OBCS regardless of the techniques and materials they used. The primary endpoint will be PROs, which include BREAST-Q, quality of life (EORTC QLQ-C30), EORTC QLQ-BR23). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to to sign the informed consent and will be followed up 24 months after operations. All data will be collected using an app software.

Conditions

• Patient Reported Outcome Measures
• Breast Reconstruction
• Oncoplastic Breast-conserving Surgery
• Breast Cancer

Interventions

PROCEDURE

breast reconstruction

The breast reconstruction mainly included autologous tissue flaps (latissimus dorsi myocutaneous flaps, pedicled tansverse rectus abdominis myocutaneous flaps, free transverse rectus abdominis musculocutaneous flaps, deep inferior epigastric artery perforator flaps, etc.), implant based breast reconstruction, autologous flaps combined with implant reconstruction, fat graft, etc.

PROCEDURE

oncoplastic breast-conserving surgery

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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• Hunan Province Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

  collaborator UNKNOWN

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• Fudan University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2024-12-30

Completion

2024-12-30

Countries

• China

Study Locations