ChiCTR2400082617 版本V1.0 版本创建时间2024/04/01 23:34:11 中国临床试验注册中心

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Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400082617 

最近更新日期：

Date of Last Refreshed on：

 2024-04-01 23:34:00 

注册时间：

Date of Registration：

 2024-04-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

皮肤型红斑狼疮新型评估工具的开发和信效度检验——一项非干预性队列研究

Public title：

Development and validation of a new assessment tool for cutaneous lupus erythematosus: a non-interventional cohort study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

皮肤型红斑狼疮新型评估工具的开发和信效度检验——一项非干预性队列研究

Scientific title：

Development and validation of a new assessment tool for cutaneous lupus erythematosus: a non-interventional cohort study

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：

张子旸 

研究负责人：

龙海 

Applicant：

Ziyang Zhang 

Study leader：

Hai Long 

申请注册联系人电话：

Applicant telephone：

 +86 137 5516 8338

研究负责人电话：

Study leader's
telephone：

+86 182 2974 3206

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：

 228212233@csu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 dr.hailong@csu.edu.cn

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：

湖南省长沙市芙蓉区有色院小区

研究负责人通讯地址：

湖南省长沙市芙蓉区湘雅二医院

Applicant address：

Hunan Province, Changsha City, Furong district, non-ferrous college community graduate dormitory

Study leader's address：

Hunan Province, Changsha City, Furong district, The Second Xiangya Hospital, Central South University

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：

中南大学湘雅二医院

Applicant's institution：

The Second Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅二医院

Affiliation of the Leader：

The Second Xiangya Hospital, Central South 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：

 LYEC2024-0107

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：

中南大学湘雅二医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee, Second Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-03-27 00:00:00

伦理委员会联系人：

蒋屏

Contact Name of the ethic committee：

Jiang Ping

伦理委员会联系地址：

湖南省长沙市芙蓉区湘雅二医院精卫楼19楼伦理办公室

Contact Address of the ethic committee：

Ethics Office, 19th Floor, Jingwei Building, Furong Xiangya Second Hospital, Changsha City, Hunan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 85292476

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：

中南大学湘雅二医院

Primary sponsor：

The Second Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

湖南省长沙市芙蓉区人民中路139号

Primary sponsor's address：

139 Renmin Middle Road, Furong District, Changsha City, Hunan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

Country：

China

Province：

Hunan Province

City：

单位(医院)：

中南大学湘雅二医院

具体地址：

湖南省长沙市芙蓉区人民中路139号

Institution
hospital：

The Second Xiangya Hospital, Central South University

Address：

139 Renmin Middle Road, Furong District, Changsha City, Hunan Province

经费或物资来源：

其他项目

Source(s) of funding：

Other projects

研究疾病：

皮肤型红斑狼疮  

Target disease：

cutaneous lupus erythematosus

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

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

（1）在深度研究、修订原有评估工具的基础上提出新的皮肤型红斑狼疮评估工具—FRCLASI； （2）验证评估工具FRCLASI的有效性，即信度和效度； （3）比较FRCLASI在有效性和临床意义上与CLASI、RCLASI的优劣性； （4）探讨FRCLASI评分与CLE患者疾病活动度、严重程度的关联性，研究FRCLASI评分对于CLE的临床意义  

Objectives of Study：

(1) A new assessment tool for cutaneous lupus erythematosus, FRCLASI, was proposed on the basis of in-depth study and revision of the original assessment tool; (2) Verify the validity of the evaluation tool FRCLASI, that is, the reliability and validity; (3) To compare the effectiveness and clinical significance of FRCLASI with CLASI and RCLASI; (4) To explore the correlation between FRCLASI score and disease activity and severity of CLE patients, and to study the clinical significance of FRCLASI score for CLE

药物成份或治疗方案详述：

研究背景和立项依据 皮肤型红斑狼疮（Cutaneous Lupus Erythematosus，CLE）是一种自身免疫性皮肤疾病，常见分型是ACLE（Acute Cutaneous Lupus Erythematosus）、SCLE（Subacute Cutaneous Lupus Erythematosus）、DLE（Discoid Cutaneous Lupus Erythematosus）、LEP（Lupus Erythematosus Profundus）。CLE的皮损表现与疾病本身的严重程度与活动性相关[1]。为了评估皮肤型红斑狼疮的皮损，现已有一些评估工具，使用较多的如CLASI（Cutaneous Lupus Erythematosus Disease Area and Severity Index）和RCLASI（Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index）[2,3]。但两种工具有着明显的缺陷，即无法对CLE患者皮损面积评估，难以对皮损做出足够准确的评估，影响对病人病情的判断。 因此，我们开展大量文献调研和既往工具使用体验调研，深入了解CLASI、RCLASI建立的基础、参考内容，分析现有两种评估工具的信度、效度[2,3]，评估其目前所具备的功能作用及临床意义，衡量其评估CLE皮损的优势与不足[4-16]，同时研究其他皮肤疾病评估工具中面积的评估方案，如银屑病、特应性皮炎、痤疮、斑秃等[17-28]。在这些基础上，我们提出了一款新的皮肤型红斑狼疮评估工具，即FRCLASI（Further Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index）。FRCLASI在保留CLASI与RCLASI对体表区域的划分以及皮损识别的基础上，增加对于皮损面积的评估方案，更精准地对病人皮损受累的情况进行评估。我们将对FRCLASI的信度和效度进行验证，并探索其评分与疾病活动度、严重程度的关联性。FRCLASI能更加准确地评估CLE病人的疾病活动性和损害程度，更全面把握病情，及时、积极地调整治疗手段，改善预后，提高患者生活质量，减轻疾病负担，为药物临床试验提供评估手段，在推动临床实践、科学研究和提升社会效益方面有重要意义。 研究对象 源人群：湘雅二医院、中国医学科学院皮肤病医院门诊、住院病人。 研究对象纳入标准：临床确诊的各型CLE患者。CLE确诊参考中华医学会皮肤性病学分会红斑狼疮研究中心《皮肤型红斑狼疮诊疗指南（2019版）》[29]，综合临床表现、实验室检查、病理表现（如有）进行诊断。不限性别，年龄3-75岁。 排除标准：1.存在精神异常或视力、听力障碍等妨碍完成评估流程的病人；2.知情同意过程中拒绝参加的病人；3.诊断错误的病人。 研究方案 为验证FRCLASI的有效性，我们分工具修订、小样本验证和工具反复修改以及正式验证三个阶段来进行验证： 一、工具修订： （1）根据文献调研和既往使用体验提出FRCLASI初步方案； （2）根据Delphi专家调查法对FRCLASI初步方案进行修订： ①确定FRCLASI相关需要讨论的问题以并制订问卷； ②组建专家组：拟邀请16位皮肤科教授（龙海、陆前进、肖嵘、苏玉文、李干群、张桂英、周英、吴海竞、张静、李亚萍、邱湘宁、文海泉、颜兰香、张庆、罗双艳、付思祺）和7位主治医师（靳慧、湛意、刘昱、廖洁月、罗帅寒天、武瑞芳、张慧明）组成专家组； ③第一轮咨询：采用电子化网络平台，结合纸质问卷向专家组成员发放问卷，并附上研究相关背景材料以供理解。完成问卷调查后回收问卷，总结专家组成员对问题的回答结果并整理成表格形式反馈给专家组成员以供参考（反馈的问卷结果仅提供意见，但并不说明发表对应意见专家的具体姓名）； ④第二轮咨询：基于第一轮问卷调查的结果，对问卷进行修改，并将修改后的问卷再次下发至专家组成员以进行第二次咨询。专家组成员可以重新评估自己的观点，并基于第一轮的反馈结果做出调整； ⑤总结第二轮咨询的问卷结果，对专家组成员的意见进行综合分析，根据分析结果对FRCLASI工具进行修订。 二、小样本验证和工具反复修改： （1）建立评估小组：评估小组成员由中南大学湘雅二医院及中国医学科学院皮肤病医院教授、主治医师、研究生组成，其中包括：教授2位（龙海、陆前进），可能参与指导的教授12位（肖嵘、苏玉文、李干群、张桂英、周英、吴海竞、张静、李亚萍、邱湘宁、文海泉、颜兰香、张庆），可能参与指导的主治医生9位（靳慧、湛意、刘昱、罗双艳、付思祺、廖洁月、罗帅寒天、武瑞芳、张慧明），研究生12位（张子旸、潘雨、胡越、汤归绍、贺丽婷、罗鑫、梁清、梁辰、周玉婷、谭萱、彭子瑜、蓝泽豪），目前预计包括以上成员，但不限于以上成员。所有成员均接受过CLASI、RCLASI、FRCLASI的使用培训； （2）建立队列： ①招募20名患者，至少包括ACLE、SCLE、DLE和LEP各型2人及以上（尽可能囊括各型）； ②涵盖疾病不同严重程度（参考CLASI、RCLASI评分）； （3）评估小组使用FRCLASI、RCLASI和CLASI对各型CLE患者评分： 现场评估： ①每名患者均由2位评估成员进行现场评估，并记录每位评估成员对每位患者使用三种工具评估各自所用的时间； ②完成现场评估后对患者每处皮损以高清照片形式进行详细记录，如遇水肿、浸润、结节，应对其累及深度和广度进行记录； 回顾评估： ①根据照片及相关皮损记录，每位患者由其对应进行现场评估的2位评估成员和不同的2位评估成员进行评估，并记录每位评估成员对每位患者使用三种工具评估各自所用的时间； ②评估成员开展现场评估和对应回顾评估的时间间隔应至少1周以上； （4）专家组对本次小样本验证的结果进行讨论，根据FRCLASI评估病情的实际情况多次召开研讨会，根据Delphi法对FRCLASI的具体内容进行多次修订（Delphi法流程与第一步大体一致）。 三、正式验证： （1）建立评估小组：评估小组成员由各研究中心40名以上的主治及以上医师和研究生组成，所有成员均接受过CLASI、RCLASI、FRCLASI的使用培训； （2）建立队列：招募≥50名患者，其中包括各型CLE患者，要求ACLE≥10，SCLE≥10，DLE≥10，LEP≥5，尽可能囊括各型（可包括初步验证中的患者），同时队列需包括各严重程度和活动性皮损（要求患者至少3处皮损具有2级及以上活动度评分）与损害性皮损的CLE患者； （3）开展队列随访：根据不同CLE分型患者开展相应随访，使用CLASI、RCLASI和FRCLASI进行现场评估，并收集患者其他相关信息用以回顾评估患者皮损情况和疾病本身的活动性和严重程度。 ①ACLE和SCLE患者：每2周随访1次，共4次，②CCLE患者：每4周随访1次，共4次； 随访内容： ①每次随访由2名评估成员使用CLASI、RCLASI和FRCLASI进行现场评估，记录皮损照片及相应信息，并对患者整体皮肤健康和疼痛、瘙痒进行评估（0 - 10分模拟量表） ②另选新的2名评估成员根据照片和信息进行回顾评估（具体要求同初步验证） 观测指标及随访计划 FRCLASI的二次验证方案中涉及建立随访队列，具体如下： （1）根据不同CLE分型患者制订不同的随访频次、时间：①ACLE和SCLE患者：每2周随访1次，共4次，②CCLE患者：每4周随访1次，共4次； 随访内容： （2）①每次随访由4名评估成员使用CLASI、RCLASI和FRCLASI进行现场评估，记录皮损照片及相应信息，并对患者整体皮肤健康和疼痛、瘙痒进行评估（0 - 10分模拟量表） ②另选新的4名评估成员根据照片和信息进行回顾评估（具体要求同初步验证） 

Description for medicine or protocol of treatment in detail：

Cutaneous Lupus Erythematosus (CLE) is an autoimmune skin disease. The common subtypes were ACLE (Acute Cutaneous Lupus Erythematosus), SCLE (Subacute Cutaneous Lupus Erythematosus), and DLE (Discoid Cutaneous Lupus) Erythematosus), LEP (Lupus Erythematosus Profundus). The lesions of CLE are related to the severity and activity of the disease itself [1]. To assess skin lesions in cutaneous lupus erythematosus, a number of assessment tools are available, More commonly used are Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) Disease Area and Severity Index) [2,3]. However, the two tools have obvious defects, that is, they cannot assess the area of skin lesions in CLE patients, and it is difficult to make a sufficiently accurate assessment of the skin lesions, which affects the judgment of the patient's condition. Therefore, we conducted a large number of literature surveys and previous tool use experience surveys to gain an in-depth understanding of the foundation and reference content of CLASI and RCLASI, analyzed the reliability and validity of the two existing assessment tools [2,3], evaluated their current functional roles and clinical significance, and measured their advantages and disadvantages in assessing CLE lesions [4-16]. At the same time, the area evaluation scheme used in other skin disease evaluation tools was studied, such as psoriasis, atopic dermatitis, acne, alopecia areata, etc. [17-28]. Based on these findings, we propose a new assessment tool for Cutaneous Lupus Erythematosus (FRCLASI) (Further Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index). On the basis of retaining the division of the body surface area between CLASI and RCLASI and the identification of skin lesions, FRCLASI adds the evaluation scheme for the skin lesions area, so as to more accurately evaluate the situation of skin lesions involved in patients. We will verify the reliability and validity of FRCLASI, and explore the correlation between its score and disease activity and severity. FRCLASI can more accurately assess the disease activity and damage degree of CLE patients, grasp the condition more comprehensively, timely and actively adjust the treatment, improve the prognosis, improve the quality of life of patients, reduce the burden of disease, and provide evaluation means for drug clinical trials, which is of great significance in promoting clinical practice, scientific research and enhancing social benefits. Subjects Source population: outpatients and inpatients in the Second Xiangya Hospital and the Dermatology Hospital of Chinese Academy of Medical Sciences. Inclusion criteria: Clinically confirmed CLE patients of all types. For diagnosis of CLE, refer to Lupus Erythematosus Diagnosis and Treatment Guide (2019 edition) [29] of Lupus Erythematosus Research Center, Dermatology and Venereology Branch of the Chinese Medical Association, and make diagnosis by combining clinical manifestations, laboratory examination, and pathological findings (if any). All genders, ages 3-75 years old. Exclusion criteria: 1. Patients with mental disorders or visual and hearing impairments that hinder the completion of the assessment process; 2. Patients who refuse to participate in the informed consent process; 3. The wrong patient. In order to verify the effectiveness of FRCLASI, we conducted the verification in three stages: revision, small sample verification, repeated tool modification and formal verification. First, tool revision: (1) Put forward the preliminary FRCLASI program based on literature research and previous experience; (2) Revise the preliminary FRCLASI program according to Delphi expert survey method: (1) Identify FRCLASI related issues to be discussed and prepare questionnaires; (2) Establishment of expert group: We plan to invite 16 dermatology professors (Long Hai, Lu Qianjin, Xiao Rong, Su Yuwen, Li Ganqun, Zhang Guiying, Zhou Ying, Wu Haijing, Zhang Jing, Li Yping, Qiu Xiangning, Wen Haiquan, Yan Lanxiang, Zhang Qing, Luo Shuangyan, Fu Siqi) and 7 attending physicians (Jin Hui, Zhan Yi, Liu Yu, Liao Jieyue, Luo Shuai Han Tian, Wu Ruifang, Zhang Huiming) to form an expert group; ③ The first round of consultation: Using the electronic network platform, combined with paper questionnaires, questionnaires were distributed to the members of the expert group, and background materials related to the research were attached for understanding. After completing the questionnaire survey, collect the questionnaires, summarize the answers of the expert group members to the questions, organize them into a form and feedback them to the expert group for reference (the feedback questionnaire results only provide opinions, but do not specify the specific name of the expert who gave the corresponding opinions); ④ Second round of consultation: Based on the results of the first round of questionnaire survey, the questionnaire was modified, and the revised questionnaire was sent to the members of the expert group again for the second consultation. Panelists can reassess their views and make adjustments based on the first round of feedback; ⑤ Summarize the questionnaire results of the second round of consultation, conduct a comprehensive analysis of the opinions of expert group members, and revise the FRCLASI tool according to the analysis results. (1) Establish an evaluation team: The evaluation team consists of professors, attending physicians and graduate students from the Second Xiangya Hospital of Central South University and the Dermatology Hospital of Chinese Academy of Medical Sciences, including: There are 2 professors (Long Hai, Lu Qianjin), 12 professors (Xiao Rong, Su Yuwen, Li Ganqun, Zhang Guiying, Zhou Ying, Wu Haijing, Zhang Jing, Li Yping, Qiu Xiangning, Wen Haiquan, Yan Lanxiang, Zhang Qing) who may participate in the guidance, 9 attending doctors (Jin Hui, Zhan Yi, Liu Yu, Luo Shuangyan, Fu Siqi, Liao Jieyue, Luo Shuai Hantian, Wu Ruifang, Zhang Huiming) who may participate in the guidance. All members have received training on the use of CLASI, RCLASI and FRCLASI; (2) Establish a cohort: ① Recruit 20 patients, including at least 2 or more patients of each type of ACLE, SCLE, DLE and LEP (including all types as much as possible); ② Covering different severity of diseases (refer to CLASI and RCLASI scores); (3) The evaluation team used FRCLASI, RCLASI and CLASI to score CLE patients of each type: On-site evaluation: 1) Each patient was evaluated by two evaluators, and the time spent by each evaluator using the three tools for each patient was recorded; (2) After the on-site evaluation, each lesion of the patient should be recorded in detail in the form of high-definition photos. In case of edema, infiltration, and nodules, the depth and breadth of involvement should be recorded; Retrospective evaluation: (1) According to the photos and related lesion records, each patient was evaluated by two evaluators and two different evaluators, and the time spent by each evaluator using the three tools for each patient was recorded; ② The interval between the on-site assessment and the corresponding retrospective assessment should be at least 1 week; (4) The expert group discussed the results of this small sample verification, held several seminars according to the actual condition assessment of FRCLASI, and revised the specific contents of FRCLASI several times according to the Delphi method (the process of Delphi method is generally consistent with the first step). (1) Establish an evaluation team: The evaluation team consists of more than 40 attending physicians and graduate students from each research center, all of whom have received training in the use of CLASI, RCLASI and FRCLASI; (2) Create a queue: Recruit ≥50 patients, including patients with all types of CLE, requiring ACLE≥10, SCLE≥10, DLE≥10, LEP≥5, including as many types as possible (may include patients in preliminary validation). At the same time, the cohort should include CLE patients with all severity and active lesions (patients should have at least 3 lesions with grade 2 or above activity score) and injurative lesions. (3) Conduct cohort follow-up: Conduct follow-up according to patients with different CLE types, use CLASI, RCLASI and FRCLASI for on-site assessment, and collect other relevant information from patients for retrospective assessment of skin lesions and the activity and severity of the disease itself. Patients with ACLE and SCLE: follow-up once every 2 weeks, a total of 4 times; patients with CCLE: follow-up once every 4 weeks, a total of 4 times; Follow-up contents: ① On-site assessment was performed by 2 evaluators using CLASI, RCLASI and FRCLASI for each follow-up visit, and photos of lesions and corresponding information were recorded. The patients' overall skin health, pain and pruritch were evaluated (0-10 score simulation scale) ② Two new evaluators were selected to conduct a retrospective evaluation based on photos and information (specific requirements and preliminary verification). Observational indicators and follow-up plan FRCLASI's secondary verification plan involved the establishment of a follow-up cohort, as follows: (1) Follow-up frequency and time were different according to different CLE types: (1) ACLE and SCLE patients were followed up once every 2 weeks, a total of 4 times; (2) CCLE patients were followed up once every 4 weeks, a total of 4 times; Follow-up contents: (2) At each follow-up visit, 4 evaluators conducted on-site assessment using CLASI, RCLASI and FRCLASI, and recorded photos of lesions and corresponding information. The patients' overall skin health, pain and pruritus were evaluated (0-10 points simulation scale) ② 4 new evaluators were selected for retrospective evaluation based on photos and information (specific requirements and preliminary verification). 

纳入标准：

1: 临床确诊的各型CLE患者。CLE确诊参考中华医学会皮肤性病学分会红斑狼疮研究中心《皮肤型红斑狼疮诊疗指南（2019版）》，综合临床表现、实验室检查、病理表现（如有）进行诊断。不限性别，年龄3-75岁。

Inclusion criteria

1: Clinically confirmed CLE patients of all types. Diagnosis of CLE refer to Lupus Erythematosus of Skin type (2019 edition), Lupus Erythematosus Research Center, Dermatology and Venereology Branch of the Chinese Medical Association, and make diagnosis by combining clinical manifestations, laboratory tests, and pathological findings (if any). All genders, ages 3-75 years old.

排除标准：

1: 1.存在精神异常或视力、听力障碍等妨碍完成评估流程的病人； 2.知情同意过程中拒绝参加的病人； 3.诊断错误的病人。

Exclusion criteria：

1: 1. Patients with mental disorders or visual and hearing impairments that prevent them from completing the assessment process 2: 2. Patients who refuse to participate in the informed consent process 3: 3. The wrong patient.

研究实施时间：

Study execute time：

从 From 2024-03-30 00:00:00至 To 2025-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-01 00:00:00 至 To 2025-05-31 00:00:00

干预措施：

Interventions：

组别：

皮肤型红斑狼疮患者队列

样本量：

 70

Group：

Cohort of cutaneous lupus erythematosus patients

Sample size：

干预措施：

无干预措施

干预措施代码：

Intervention：

No intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

  

Country：

China

Province：

Hunan Province

City：

单位(医院)：

 中南大学湘雅二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Xiangya Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

皮损图片

指标类型：

主要指标

Outcome：

Lesion picture

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮肤健康和疼痛、 瘙痒

指标类型：

次要指标

Outcome：

Skin health, pain and pruritus

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：

标本中文名：

无标本

组织：

Sample Name：

No sample

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age 75 岁 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

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

None

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：

Blinding：

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）：

不共享

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

No sharing

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：

1.数据收集录入： 在小样本验证和正式验证过程中，对已收集的患者的信息进行妥善保存。主要通过电子文档形式录入患者基本信息（姓名、年龄、性别、门诊/住院病历号）、病例信息（主诉、现病史、既往史、诊断）、门诊复查的抽血化验结果（血、尿常规、血沉、补体、ANA、抗dsDNA抗体），用相机记录患者皮损情况，并以电子照片形式保存患者信息。研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入患者对应的病例报告。经过监察员审核、签字后的调查表应及时送交临床研究数据管理员。 录入采用相应的数据库系统双人双机录入，之后对数据库进行两遍比对，期间若发现问题及时通知研究者，要求研究者做出回答。他们之间的各种疑问及解答的交换应当采用疑问表形式，疑问表应保存备查。 2.数据核查和管理 当所有病例报告表经双份输入并核对无误后，由数据管理员写出数据库检查报告，其内容包括研究完成情况（含脱落受试者清单）、入选/排除标准检查、完整性检查、逻辑一致性检查等。在审核会议上，由主要研究者、申办单位代表、监查员、数据管理员和统计人员对受试者签署知情同意书、数据库检查报告中提出的问题做出决议，写出审核报告，数据库同时将被锁定。 3.数据存档 病例报告在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，应分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按相应规定内的期限保存。

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

1. Data collection and entry: In the process of small sample verification and formal verification, the collected patient information is properly stored. The patient's basic information (name, age, gender, outpatient/inpatient medical record number), case information (chief complaint, present history, past history, diagnosis), blood test results of outpatient review (blood, urine routine, sedimentation rate, complement, ANA, anti-DSDNA antibody) were recorded in the form of electronic documents, and the patient's skin lesions were recorded with cameras. Patient information is stored in the form of electronic photographs. According to the original observation records of the subjects, the data will be timely, complete, correct and clear into the patient's corresponding case report. The questionnaire, which has been reviewed and signed by the ombudsman, should be sent to the clinical study data Manager in a timely manner. The corresponding database system was used for two-person and two-machine input, and then the database was compared twice. During the period, if any problem was found, the researcher was promptly notified and asked to answer. The exchange of questions and answers between them shall be in the form of a question table, which shall be kept for future reference. 2. Data verification and management After all the case report forms are entered and verified correctly, the data manager writes the database inspection report, which includes the study completion status (including the list of dropped subjects), the inclusion/exclusion criteria check, the integrity check, the logical consistency check, etc. At the audit meeting, the main researcher, the representative of the bidding unit, the supervisor, the data administrator and the statistician will make a decision on the informed consent signed by the subjects and the problems raised in the database inspection report, write the audit report, and the database will be locked. 3. Data archive After data entry and verification are completed as required, case reports shall be archived and stored in numbered order and filled with search directories for reference. Electronic data files, including databases, inspection programs, analysis programs, analysis results, coding and explanatory files, should be classified and stored in different disks or recording media with multiple backups, properly stored to prevent damage. All original files shall be kept for the period specified accordingly.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-04-01 23:34:00