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IS PREDICTION OF LOCAL RECURRENCE POSSIBLE IN PAGET’S DISEASE OF THE BREAST?
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注册号：

Registration number：

 ChiCTR2000032336 

最近更新日期：

Date of Last Refreshed on：

 2020-04-26 06:47:08 

注册时间：

Date of Registration：

 2020-04-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

IS PREDICTION OF LOCAL RECURRENCE POSSIBLE IN PAGET’S DISEASE OF THE BREAST?

Public title：

IS PREDICTION OF LOCAL RECURRENCE POSSIBLE IN PAGET’S DISEASE OF THE BREAST?

注册题目简写：

English Acronym：

研究课题的正式科学名称：

IS PREDICTION OF LOCAL RECURRENCE POSSIBLE IN PAGET’S DISEASE OF THE BREAST?

Scientific title：

IS PREDICTION OF LOCAL RECURRENCE POSSIBLE IN PAGET’S DISEASE OF THE BREAST?

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Assoc. Prof Sevim Turanli 

研究负责人：

Assoc. Prof Sevim Turanli 

Applicant：

Assoc. Prof Sevim Turanli 

Study leader：

Assoc. Prof Sevim Turanli 

申请注册联系人电话：

Applicant telephone：

 +90 54 46836530

研究负责人电话：

Study leader's
telephone：

+90 54 46836530

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 turanlisevim@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 turanlisevim@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eit. ve Ara. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200, TURKEY

研究负责人通讯地址：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eit. ve Ara. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200, TURKEY

Applicant address：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eit. ve Ara. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200, TURKEY

Study leader's address：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eit. ve Ara. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200, TURKEY

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

土耳其安卡拉肿瘤学教育和研究医院

Applicant's institution：

SBU, Ankara Oncology Education and Research Hospital

研究负责人所在单位：

土耳其安卡拉肿瘤学教育和研究医院

Affiliation of the Leader：

SBU, Ankara Oncology Education and Research Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 20033663

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

SBU, Ankara Oncology Education and Research Hospital, Ethical Committee

Name of the ethic committee：

SBU, Ankara Oncology Education and Research Hospital, Ethical Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Assoc. Prof. Suat Kutun

Contact Name of the ethic committee：

Assoc. Prof. Suat Kutun

伦理委员会联系地址：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eit. ve Ara. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200/TURKEY

Contact Address of the ethic committee：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eit. ve Ara. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200/TURKEY

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

SBU, Ankara Oncology Education and Research Hospital

Primary sponsor：

SBU, Ankara Oncology Education and Research Hospital

研究实施负责（组长）单位地址：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eğit. ve Araş. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200/TURKEY

Primary sponsor's address：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji Eğit. ve Araş. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle/Ankara, 06200/TURKEY

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

土耳其

省(直辖市)：

安卡拉

市(区县)：

Country：

Turkey

Province：

Ankara

City：

单位(医院)：

安卡拉肿瘤学教育和研究医院

具体地址：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji E?it. ve Ara?. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle

Institution
hospital：

SBU, Ankara Oncology Education and Research Hospital

Address：

Dr.Abdurrahman Yurtaslan Ankara Onkoloji E?it. ve Ara?. Hastanesi Mehmet Akif Ersoy Mahallesi 13. Cadde No:56 Yenimahalle

经费或物资来源：

own funding

Source(s) of funding：

own funding

研究疾病：

Mammary Paget'S disease  

Target disease：

Mammary Paget'S disease

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

Mammary Paget disease of the breast is rare form of breast cancer. Recent trends in the management has changed from mastectomy to breast conserving surgery, its safety is still controversial. The study aimed to predict the patients prone to local recurrence, and to find out the answer to the question of who should be a candidate for breast conserving surgery.  

Objectives of Study：

Mammary Paget disease of the breast is rare form of breast cancer. Recent trends in the management has changed from mastectomy to breast conserving surgery, its safety is still controversial. The study aimed to predict the patients prone to local recurrence, and to find out the answer to the question of who should be a candidate for breast conserving surgery.

药物成份或治疗方案详述：

Between January 2007 and December 2017, 69 patients who underwent surgery and pathology report diagnosed as Paget’s disease, were analyzed retrospectively. As factors that may affect local recurrence; age, presence of nipple symptoms, mass detection in radiological imaging, type of the surgery, stage, pathological findings of the tumor (histological type, multicentricity, ER, PR, HER2, Ki 67 proliferative index, molecular subtype) were evaluated.  

Description for medicine or protocol of treatment in detail：

Between January 2007 and December 2017, 69 patients who underwent surgery and pathology report diagnosed as Pagets disease, were analyzed retrospectively. As factors that may affect local recurrence; age, presence of nipple symptoms, mass detection in radiological imaging, type of the surgery, stage, pathological findings of the tumor (histological type, multicentricity, ER, PR, HER2, Ki 67 proliferative index, molecular subtype) were evaluated.  

纳入标准：

Inclusion criteria

排除标准：

Eleven patients with a synchronous other primary malignancy or who did not come to regular follow-up, were excluded.

Exclusion criteria：

Eleven patients with a synchronous other primary malignancy or who did not come to regular follow-up, were excluded.

研究实施时间：

Study execute time：

从 From 2020-04-25 00:00:00至 To 2020-04-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-04-25 00:00:00 至 To 2020-04-25 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 69

Group：

Case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Turkey

省(直辖市)：

 Ankara 

市(区县)：

  

Country：

Turkey

Province：

Ankara

City：

单位(医院)：

 SBU, Ankara Oncology Education and Research Hospital 

单位级别：

 University 

Institution
hospital：

SBU, Ankara Oncology Education and Research Hospital

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

The best surgical intervention

指标类型：

主要指标

Outcome：

The best surgical intervention

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Patology report

组织：

Sample Name：

Patology report

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 33 岁 years
最大 Max age 77 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

non randomized

Randomization Procedure (please state who generates the random number sequence and by what method)：

non randomized

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

None

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

sent for publication

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

sent for publication

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

hospital own data system

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

hospital own data system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-04-26 06:37:34
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