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Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol

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机构: [1]Department of Breast Surgery, Shanghai Cancer Hospital, Fudan University,Shanghai, China [2]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai,China [3]Department of Endocrine and Breast Surgery, The First Affiliated Hospital ofChongqing Medical University, Chongqing, Sichuan, China [4]Department of Breast Oncoplastic Surgery, Tianjin Medical University CancerInstitute and Hospital, Tianjin, Tianjin, China [5]Department of Breast Surgery, The First Affiliated Hospital of China MedicalUniversity, Shenyang, Liaoning, China [6]Department of Breast Cancer, Guangdong Provincial People’s Hospital, Guangzhou,Guangdong, China [7]Department of Plastic Surgery, Jiangsu Province Hospital and Nanjing MedicalUniversity First Affiliated Hospital, Nanjing, Jiangsu, China [8]Department of Thyroid, Breast and Vascular Surgery, Xijing Hospital, Air ForceMedical University, Xian, China [9]Department of Oncology, Plastic Surgery, Hunan Province Cancer Hospital,Changsha, China [10]Department of Breast Surgery, Hunan Province Cancer Hospital, Changsha, China [11]Department of Breast Surgical Oncology, National Cancer Center, Beijing, China [12]Department of Breast Surgical Oncology, National Clinical Research Center forCancer, Beijing, China [13]Department of Breast Surgical Oncology, Cancer Hospital, Chinese Academy ofMedical Sciences and Peking Union Medical College, Beijing, China [14]Department of Breast Surgery, The First Affiliated Hospital, Zhejiang University,School of Medicine, Hangzhou, Zhejiang, China [15]Department of Breast Surgery, The First Affiliated Hospital of Xiamen University,Xiamen, Fujian, China [16]Department of Breast and Head & Neck, Affiliated Cancer Hospital of XinjiangMedical University, Urumqi, China [17]Breast Cancer Center, Hubei Cancer Hospital, Tongji Medical College, HuazhongUniversity of Science & Technology, Wuhan, Hubei, China [18]Breast Disease Center, The Affiliated Hospital of Qingdao University, Qingdao,Shandong, China [19]Department of Breast Surgery, Affiliated Hangzhou First People’s Hospital,Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China [20]Collaborative Innovation Center for Cancer Medicine, Shanghai, China
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关键词: Breast reconstruction Breast tumours Cohort Oncoplastic breast-conserving surgery Patient reported outcome measures Study protocol

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Introduction Available patient-reported outcome (PRO) studies are mainly from single institution or of small sample size, and the variations across hospitals and regions were not fully analysed. A multicentre, prospective, patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs of Chinese patients with breast cancer who will undergo breast reconstruction (BR) or oncoplastic breast-conserving surgery (OBCS). Methods and analysis The inclusion criteria are female patients with breast cancer aged >18 years old who will undergo BR or OBCS. This cohort will include at least 10 000 consecutive patients (about 5000 patients who will undergo BR and 5000 patients who will undergo OBCS). The exposures were surgery types: BR and OBCS regardless of the techniques and materials used. The primary endpoint will be PROs, which include BREAST-Q and quality of life (European Organisation for Research and Treatment (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and EORTC QoL Breast Cancer-specific version (QLQ-BR23)). All patients will be followed up to 24 months after operations. All data will be prospectively collected using an app software. Data will be analysed using SPSS and Stata software. Ethics and dissemination This study follows the Helsinki Declaration. All patients will be asked to sign an informed consent before enrolment. The results of this study will be presented at national and international meetings and published in a scientific peer-reviewed journal.

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出版当年[2019]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
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出版当年[2019]版:
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

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第一作者机构: [1]Department of Breast Surgery, Shanghai Cancer Hospital, Fudan University,Shanghai, China [2]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai,China
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通讯机构: [1]Department of Breast Surgery, Shanghai Cancer Hospital, Fudan University,Shanghai, China [2]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai,China [20]Collaborative Innovation Center for Cancer Medicine, Shanghai, China
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