Patient Report Outcome-Reconstruction and Oncoplastic Cohort

Last updated: July 23, 2019
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Reconstruction

Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT04030845
SCHBCC-N023
  • Ages 18-85
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Breast cancer patients;

  2. Adult (>18 years old);

  3. Female;

  4. Must undergo breast reconstruction or oncoplastic breast-conserving surgery;

Exclusion

Exclusion Criteria:

  1. Younger (<18 years old);

  2. Male;

  3. Stage IV breast cancer patients;

  4. Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.

Study Design

Total Participants: 10000
Study Start date:
July 01, 2019
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • Shanghai Cancer Center, Fudan University

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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