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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: |
ChiCTR2200062950 |
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最近更新日期: Date of Last Refreshed on: |
2023-04-07 13:06:40 |
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注册时间: Date of Registration: |
2022-08-25 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
中国成人甲状腺功能亢进症(甲亢)及其合并肝损伤治疗情况的登记注册研究 |
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Public title: |
A registered study: the treatment of hyperthyroidism and its associated liver injury in Chinese adults |
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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: |
中国成人甲状腺功能亢进症(甲亢)及其合并肝损伤治疗情况的登记注册研究 |
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Scientific title: |
A registered study: the treatment of hyperthyroidism and its associated liver injury in Chinese adults |
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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: |
沈苏敏 |
研究负责人: |
童南伟 |
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Applicant: |
ShenSuMin |
Study leader: |
TongNanwei |
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申请注册联系人电话: Applicant telephone: |
18081958109 |
研究负责人电话:
Study leader's |
18980601196 |
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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: |
1540674946@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
tongnanwei@aliyun.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: |
四川省成都市国学巷37号 |
研究负责人通讯地址: |
四川省成都市国学巷37号 |
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Applicant address: |
No. 37, Guoxue lane, Chengdu, Sichuan |
Study leader's address: |
No. 37, Guoxue lane, Chengdu, Sichuan |
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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: |
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申请人所在单位: |
四川大学华西医院 |
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Applicant's institution: |
West China Hospital of Sichuan University |
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研究负责人所在单位: |
四川大学华西医院 |
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Affiliation of the Leader: |
West China Hospital, Sichuan 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: |
2022年审504号 |
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: |
四川大学华西医院生物医学伦理审查委员会 |
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Name of the ethic committee: |
Ethics Committee on Biomedical Research, West China Hospital of Sichuan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2022-03-30 00:00:00 | ||
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伦理委员会联系人: |
李娜 |
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Contact Name of the ethic committee: |
LiNa |
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伦理委员会联系地址: |
四川省成都市国学巷37号 |
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Contact Address of the ethic committee: |
No. 37, Guoxue lane, Chengdu, Sichuan |
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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: |
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研究实施负责(组长)单位: |
四川大学华西医院 |
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Primary sponsor: |
West China Hospital of Sichuan University |
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研究实施负责(组长)单位地址: |
四川省成都市国学巷37号 |
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Primary sponsor's address: |
No. 37, Guoxue lane, Chengdu, Sichuan |
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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: |
成都旺茂顺科技有限公司 |
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Source(s) of funding: |
Chengdu Wangmaoshun Technology Co., Ltd |
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研究疾病: |
甲状腺功能亢进症及其合并肝损伤 |
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Target disease: |
Hyperthyroidism and associated liver injury |
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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: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
主要目的: 1.评估.中国真实世界甲亢患者接受ATD、RAI或手术治疗的临床疗效及转归情况 2.评估甲亢患者接受ATD、RAI或手术治疗的安全性 3.评估甲亢患者合并肝损伤的情况(甲亢前已存在的肝损伤、甲亢性肝损伤以及ATD致肝损伤) 4.甲亢性肝损伤和ATD致肝损伤接受保肝治疗的临床疗效及转归情况 次要目的: 1.评估甲亢患者接受ATD、RAI、手术治疗或观察的比例 2.了解甲亢治疗期间治疗方案变化情况 3.评估我国医生对当时国际或国内甲亢治疗指南的执行情况 4.评估影响病情缓解或复发的因素 5.评估影响不良事件发生的因素 6.评估ATD治疗的依从性 7.评估ATD停药时间或2年停药率 8.评估GD甲亢严重度与ATD剂量的关系 9.评估ATD剂量、RAI剂量和手术方式与疗效和不良事件的关系 其他:评估接受治疗的甲亢病因、伴发疾病、遗传情况、妊娠结局等。 |
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Objectives of Study: |
The main purpose of: 1.To evaluate the clinical efficacy and outcome of hyperthyroidism patients receiving ATD, rai or surgery in the real world of China 2.To evaluate the safety of hyperthyroidism patients receiving ATD, rai or surgery 3.Evaluate the situation of hyperthyroidism patients with liver injury (liver injury before hyperthyroidism, hyperthyroidism liver injury and liver injury caused by ATD) 4.Clinical efficacy and prognosis of hyperthyroid liver injury and liver injury caused by ATD treated with liver protection therapy A secondary purpose: 1.The proportion of patients with hyperthyroidism who received ATD, RAI, surgical treatment or observation was evaluated 2.To understand the change of treatment plan during the treatment of hyperthyroidism 3.To evaluate the implementation of Chinese doctors' guidelines for the treatment of hyperthyroidism at that time 4.Assess factors that influence response or recurrence 5.Evaluate the factors influencing the occurrence of adverse events 6.Adherence to ATD treatment was assessed 7.ATD discontinuation time or 2-year discontinuation rate was evaluated 8.To evaluate the relationship between GD hyperthyroidism severity and ATD dose 9.To evaluate the relationship between ATD dose, RAI dose and surgical method with efficacy and adverse events other:To evaluate the causes of hyperthyroidism, concomitant diseases, genetic conditions, pregnancy outcomes, etc |
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药物成份或治疗方案详述: |
无 |
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Description for medicine or protocol of treatment in detail: |
none |
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纳入标准: |
1.符合2016年美国甲状腺学会(ATA)、2018年欧洲甲状腺学会(ETA)或中华医学会内分泌学分会等权威组织制定的甲状腺功能亢进症的诊断标准; |
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Inclusion criteria |
1.It meets the diagnostic criteria of hyperthyroidism formulated by authoritative organizations such as the American Thyroid Association (ATA) in 2016, the European Thyroid Association (ETA) in 2018 or the endocrinology branch of the Chinese Medical Association; |
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排除标准: |
1.不愿签署知情同意书; |
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Exclusion criteria: |
1.Unwilling to sign informed consent; |
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研究实施时间: Study execute time: |
从 From 2022-02-01 00:00:00至 To 2025-03-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2022-09-01 00:00:00 至 To 2024-05-31 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: |
尚未开始 Not yet 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): |
非干预性研究,无分组 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Non-intervention study, no grouping |
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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: |
无 |
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Blinding: |
none |
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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): |
仅参与研究单位可以申请共享。数据计划在研究完成后开始共享、数据共享长期持续、共享此研究期间研究收集到的所有内容。 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Only participating research units can apply for sharing. Data sharing is planned to begin after the completion of the study, and data sharing will continue for a long time, sharing all the content col |
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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: |
本研究采用电子数据采集(EDC)系统进行数据采集。数据录入人员应根据《eCRF填写指南》将原始资料信息及时、准确、完整、规范地录入EDC。只有经过EDC操作培训合格的研究者或CRC等人员被授权后才能执行数据录入工作。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
The electronic data acquisition (EDC) system was used for data acquisition in this study. Data entry personnel shall input the original data information into EDC in a timely, accurate, complete and standard manner according to the eCRF Filling Guide. Only authorized researchers or CRC personnel who have been trained in EDC operation can perform data entry. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |