NCT04030845

Patient Report Outcome-Reconstruction and Oncoplastic Cohort

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2019-07-24
• Last updated: 2019-07-25

Locations

1 site across 1 country: China