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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2600120437 |
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最近更新日期: Date of Last Refreshed on: |
2026-03-13 17:23:35 |
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注册时间: Date of Registration: |
2026-03-13 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
接受肠镜检查人群生活习惯的调查-多中心横断面研究 |
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Public title: |
Survey of Lifestyle Habits Among Individuals Undergoing Colonoscopy: A Multicentre Cross-Sectional Study |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
接受肠镜检查人群生活习惯的调查 |
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Scientific title: |
Survey on Lifestyle Habits of Individuals Undergoing Colonoscopy |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
黄昌伟 |
研究负责人: |
郭瑾陶 |
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Applicant: |
Changwei Huang |
Study leader: |
Jintao Guo |
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申请注册联系人电话: Applicant telephone: |
+86 131 3081 7919 |
研究负责人电话:
Study leader's |
+86 189 4025 6654 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
hcwdoctor@163.com |
研究负责人电子邮件: Study leader's E-mail: |
guojt@sj-hospital.com |
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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): |
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申请注册联系人通讯地址: |
辽宁省沈阳市和平区三好街36号 |
研究负责人通讯地址: |
辽宁省沈阳市和平区三好街36号 |
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Applicant address: |
No. 36 Sanhao Street, Heping District,Shengyang,Liaoning |
Study leader's address: |
No. 36 Sanhao Street, Heping District,Shengyang,Liaoning |
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申请注册联系人邮政编码: Applicant postcode: |
110004 |
研究负责人邮政编码: Study leader's postcode: |
110004 |
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申请人所在单位: |
中国医科大学附属盛京医院 |
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Applicant's institution: |
Shengjing Hospital of China Medical University |
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研究负责人所在单位: |
中国医科大学附属盛京医院 |
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Affiliation of the Leader: |
Shengjing Hospital of China Medical University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2024PS1029K |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
中国医科大学附属盛京医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Shengjing Hospital Affiliated to China Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-04-29 00:00:00 | ||
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伦理委员会联系人: |
郭传骥 |
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Contact Name of the ethic committee: |
Chuanji Guo |
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伦理委员会联系地址: |
辽宁省沈阳市和平区三好街36号 |
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Contact Address of the ethic committee: |
No. 36 Sanhao Street, Heping District,Shengyang,Liaoning |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 966 1510027 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
中国医科大学附属盛京医院 |
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Primary sponsor: |
Shengjing Hospital Affiliated to China Medical University |
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研究实施负责(组长)单位地址: |
辽宁省沈阳市和平区三好街36号 |
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Primary sponsor's address: |
No. 36 Sanhao Street, Heping District,Shengyang,Liaoning |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家优秀青年医师 (V025/MV025);植树计划(M1595);国家卫生健康委能力建设和继续教育中心慢病管理研究课题(GWJJMB202510022196); |
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Source(s) of funding: |
This study was supported by the National High-Level Talent Program (Outstanding Young Physicians) (V025/MV025);Chronic Disease Management Research Project of National Health Commission Capacity Building and Continuing Education Center(GWJJMB202510022196), The Tree Planting Program of Shengjing Hospital (M1595); |
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研究疾病: |
肠息肉 |
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Target disease: |
Colonic polyps |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
识别结直肠息肉的高危人群,并指导高危人群的生活习惯。 |
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Objectives of Study: |
Identify high-risk populations for colorectal polyps and provide lifestyle guidance for those at elevated risk. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.年龄为20-80岁 2.经过肠镜确诊为没有息肉和有息肉的 3.无炎症性肠病 4.没有特殊的饮食禁忌以及特殊饮食人群(运动员,孕妇等) |
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Inclusion criteria |
1.Aged between 20 and 80 years; 2. Confirmed via colonoscopy to be either polyp-free or polyp-bearing; 3. No inflammatory bowel disease; 4. No specific dietary restrictions or special dietary requirements (e.g. athletes, pregnant women). |
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排除标准: |
1.未签署知情同意 2.严重的内外科病变 3.有食物过敏史 4.黑色素瘤 |
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Exclusion criteria: |
1.Failure to sign informed consent; 2. Severe internal or surgical pathology; 3. History of food allergies; 4. Melanoma. |
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研究实施时间: Study execute time: |
从 From 2024-05-07 00:00:00至 To 2030-02-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2024-05-07 00:00:00 至 To 2030-02-01 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
NA |
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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 |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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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): |
试验全部完成,数据完成清洗后;http://www.medresman.org.cn/login.aspx |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
After all tests are completed and data cleaning is finished;:http://www.medresman.org.cn/login.aspx |
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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: |
CRF |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
CRF |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |