今天是:2019-11-22 星期五

不同术式对中低危分化型甲状腺癌患者生存质量影响的前瞻性研究
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注册号:

Registration number:

ChiCTR1900025709 

最近更新日期:

Date of Last Refreshed on:

2019-09-06 

注册时间:

Date of Registration:

2019-09-06 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

不同术式对中低危分化型甲状腺癌患者生存质量影响的前瞻性研究 

Public title:

Effects of different operations on the quality of life of differentiated thyroid cancer survivors with low-median risk of recurrence 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同术式对中低危分化型甲状腺癌患者生存质量影响的前瞻性研究 

Scientific title:

Effects of different operations on the quality of life of differentiated thyroid cancer survivors with low-median risk of recurrence 

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:

陈玩娜 

研究负责人:

吕伟明 

Applicant:

Wanna Chen 

Study leader:

Weiming Lv 

申请注册联系人电话:

Applicant telephone:

+86 18924086568 

研究负责人电话:

Study leader's telephone:

+86 13925177549 

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:

fdchenwanna@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fdchenwanna@163.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:

广东省广州市中山二路58号5号楼20楼甲乳外科 

研究负责人通讯地址:

广东省广州市中山二路58号5号楼20楼甲乳外科 

Applicant address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

中山大学附属第一医院 

Applicant's institution:

the First Affiliated Hospital, Sun Yat-sen University 

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:

伦审[2019]275号 

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:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

Clinical Research and Experimental Animal Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-05 

伦理委员会联系人:

林海峰 

Contact Name of the ethic committee:

Haifeng Lin 

伦理委员会联系地址:

广州市中山二路58号 

Contact Address of the ethic committee:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第一医院

具体地址:

广东省广州市中山二路58号

Institution
hospital:

The First Affiliated Hospital, Sun Yat-sen University

Address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

经费自筹 

Source(s) of funding:

self-financing 

研究疾病:

分化型甲状腺癌 

Target disease:

differentiated thyroid carcinoma 

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:

其它 

Study phase:

N/A 

研究目的:

本课题希望通过前瞻性队列研究,关注中低危分化型甲状腺癌(DTC)患者不同术式后生活质量的改变,比较甲状腺全切术和甲状腺腺叶切除术对其生活质量的影响,为中低危DTC术式的选择提供依据。 

Objectives of Study:

The objective of this study is to compare quality of life of patients with low/median-risk differentiated thyroid cancer(DTC) who underwent total thyroidectomy or lobectomy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 年龄≥18周岁 2. 穿刺或手术病理为分化型甲状腺癌 3. 临床中低危复发风险 4. 具备基本读写能力、无沟通交流障碍 5. 患者知情同意,自愿参加 

Inclusion criteria

1. Aged >=18 years old; 2. Differentiated thyroid cancer confermed by surgery or biopsy pathology; 3. With low/median-risk of recurrence; 4. Good Chinese communication skills both in written and oral; 5. Willing to accept the follow-up surveys after being informed. 

排除标准:

1. 其他恶性肿瘤病史者 2. 因甲癌复发、转移行二次手术的患者 3. 严重心肺疾病、自理能力受限的患者 4. 已有远处转移 5. 认知和行为能力障碍的患者 

Exclusion criteria:

1. Complicated with other malignant tumors; 2. Underwent reoperation due to cancer recurrence or metastasis; 3. Severe cardiopulmonary diseases with impaired self-care ability; 4. With distant metastatic disease; 5. cognition and behavior impairment. 

研究实施时间:

Study execute time:

From2018-10-01To 2020-12-31 

干预措施:

Interventions:

组别:

甲状腺全切术组

样本量:

500

Group:

total thyroidectomy group

Sample size:

干预措施:

甲状腺全切术

干预措施代码:

Intervention:

total thyroidectomy

Intervention code:

组别:

甲状腺腺叶切除术组

样本量:

500

Group:

lobectomy group

Sample size:

干预措施:

甲状腺腺叶切除术

干预措施代码:

Intervention:

lobectomy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou City 

单位(医院):

中山大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, Sun Yat-sen University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

EORTC-QLQ-C30表各维度分数

指标类型:

主要指标 

Outcome:

scores of each dimension in EORTC-QLQ-C30

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

THYCA-QoL表各维度分数

指标类型:

主要指标 

Outcome:

scores of each dimension in THYCA-QoL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HADS表各维度分数

指标类型:

主要指标 

Outcome:

scores of each dimension in HADS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

L-T4剂量

指标类型:

次要指标 

Outcome:

L-T4 dose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TSH水平

指标类型:

次要指标 

Outcome:

TSH level

Type:

Secondary 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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

无随机分组

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

No randomization.

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

实验完成后6月内公开,于ResMan临床试验公共管理平台,网址:http://wwww.medresman.org

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

within six months after the trial complete; ResMan:http://wwww.medresman.org

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:

每个患者用基本信息表、问卷收集数据,再输入电脑EpiData软件进行管理。

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

Data was collected with basic information form and quality of life questionnaires, and then uploaded to EpiData software for management.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-06
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