Patient Report Outcome-Reconstruction and Oncoplastic Cohort — PRO-ROC  

Breast Cancer Clinical Trial

Official title: Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome -Reconstruction and Oncoplastic Cohort

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

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

• NCT number: NCT04030845
• Study type: Observational [Patient Registry]
• Source: Fudan University
• Status: Recruiting
• Start date: July 1, 2019
• Completion date: December 30, 2024