ChiCTR2000036622 版本V1.1 版本创建时间2020/09/17 19:02:33 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2000036622 

最近更新日期：

Date of Last Refreshed on：

2020-08-24 11:33:11 

注册时间：

Date of Registration：

2020-08-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

整合AI智能影像和探针标记技术的肺部结节良恶性鉴别风险评估系统的建立和应用

Public title：

Establishment and application of a risk assessment system for differentiating benign and malignant pulmonary nodules based on AI intelligent imaging and probe labeling technology

注册题目简写：

English Acronym：

研究课题的正式科学名称：

整合AI智能影像和探针标记技术的肺部结节良恶性鉴别风险评估系统的建立和应用

Scientific title：

Establishment and application of a risk assessment system for differentiating benign and malignant pulmonary nodules based on AI intelligent imaging and probe labeling technology

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：

顾志冬 

研究负责人：

顾志冬 

Applicant：

GU ZHIDONG 

Study leader：

GU ZHIDONG 

申请注册联系人电话：

Applicant telephone：

13801653534

研究负责人电话：

Study leader's telephone：

13801653534

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：

13801653534@163.com

研究负责人电子邮件：

Study leader's E-mail：

13801653534@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：

上海市嘉定区希望路999号瑞金医院北院

研究负责人通讯地址：

上海市嘉定区希望路999号瑞金医院北院

Applicant address：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

Study leader's address：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

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：

上海交通大学医学院附属瑞金医院北院

Applicant's institution：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

研究负责人所在单位：

上海交通大学医学院附属瑞金医院北院

Affiliation of the Leader：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

（2020）瑞北伦审第（013）-1

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：

瑞金医院北院伦理委员会

Name of the ethic committee：

Ruijin Hospital North Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2020-08-20 00:00:00

伦理委员会联系人：

瞿介明

Contact Name of the ethic committee：

jieming qu

伦理委员会联系地址：

上海交通大学医学院附属瑞金医院北院

Contact Address of the ethic committee：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

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：

上海交通大学医学院附属瑞金医院北院

Primary sponsor：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

研究实施负责（组长）单位地址：

上海交通大学医学院附属瑞金医院北院

Primary sponsor's address：

Ruijin Hospital north,shanghai jiaotong university，school of medicine

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属瑞金医院北院

具体地址：

嘉定区希望路999号

Institution
hospital：

Ruijin Hospital North, Shanghai Jiaotong University, School of Medicine

Address：

999 Xiwang Road, Jiading District

经费或物资来源：

项目申请获得资金

Source(s) of funding：

Obtain funds through project application

Target disease：

lung cancer

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 诊断试验新技术临床试验 

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

本研究旨在评估多色FISH技术在肺部小结节良恶性诊断的价值，并通过对恶性肺结节患者和良性肺结节患者的长期随访，结合其他组学的诊断研究，进一步论证与探讨多色FISH技术联合多组学分析对早期肺癌的预测价值，预后判断和药物疗效检测价值，进一步优化现有肺结节诊疗技术与方案，为肺结节患者提供更为完善的个性化诊疗提供理论依据。 主要目的：建立智能影像诊断系统和多色FISH鉴别诊断肺部小结节良恶性的技术，并评估二者单独使用和联用在肺部小结节良恶性诊断的价值，进一步论证与探讨二者单独使用和联合多组学分析对肺癌预后判断和药物疗效监测的价值。 次要目的： 一、在恶性肺部结节切除前后分别用影像诊断系统和多色FISH技术诊断，评估智能影像诊断系统和多色FISH技术与恶性肺部结节肺癌预后判断和药物疗效监测的价值。 二、在随访过程中，通过影像学及多色FISH技术分析经非手术活检或手术活检诊断为良性结节受试者 3 年内肺部结节的变化情况，评估智能影像诊断系统及多色FISH技术在肺部小结节良恶性预测中的价值 三、对病例资料进行回顾性分析，通过研究，建立智能影像诊断系统和FISH技术联合其他组学进行肺部小结节风险评估与早期的辅助诊断模型。  

Objectives of Study：

The purpose of this study was to evaluate the value of multi-color fish technology in the diagnosis of benign and malignant pulmonary nodules, and through the long-term follow-up of patients with malignant and benign pulmonary nodules, combined with other omics diagnostic studies, further demonstrated and discussed the predictive value of multi-color fish technology combined with multi-component analysis for early lung cancer, prognosis judgment and drug efficacy detection value, and further optimize the present situation There are lung nodule diagnosis and treatment technology and scheme, which can provide more perfect personalized diagnosis and treatment for patients with pulmonary nodules. Objective: to establish the technology of intelligent imaging diagnosis system and multicolor FISH in the differential diagnosis of benign and malignant pulmonary nodules, and to evaluate the value of both alone and in combination in the diagnosis of benign and malignant pulmonary nodules, and to further demonstrate and explore the value of the two alone and combined with multi-component analysis in the prognosis judgment and drug efficacy monitoring of lung cancer. Secondary purpose: 1 Before and after resection of malignant pulmonary nodules, imaging diagnosis system and polychromatic fish technology were used to evaluate the value of intelligent imaging diagnosis system and polychromatic fish technology in prognosis judgment and drug efficacy monitoring of malignant pulmonary nodules and lung cancer. 2 During the follow-up, imaging and multi-color fish technology were used to analyze the changes of pulmonary nodules in subjects diagnosed as benign nodules by non-surgical biopsy or surgical biopsy within 3 years, and to evaluate the value of intelligent imaging diagnosis system and multi-color fish technology in the prediction of benign and malignant pulmonary nodules 3 The case data were retrospectively analyzed. Through the research, the intelligent imaging diagnosis system and fish technology combined with other omics were established to evaluate the risk of pulmonary nodules and early auxiliary diagnosis model.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

选取的资料应符合以下标准：
低剂量CT扫描影像学资料和对应的组织活检资料完整
研究对象应符合以下标准：
1、承诺遵守研究程序，并配合实施全过程研究
2、指定的性别或年龄范围
3、符合肺癌或是肺部良性疾病的疾病诊断、症状体征，或者一般健康状况良好能坚持、配合研究干预，如接受化疗治疗
4、签名的带日期的知情同意书

Inclusion criteria

The subjects should meet the following criteria:
1. Commitment to follow the research procedures and cooperate with the implementation of the whole process research
2. Specified gender or age range
3. According to the diagnosis, symptoms and signs of lung cancer or benign lung disease, or in general good health, can adhere to and cooperate with research intervention, such as chemotherapy
4. Signed and dated informed consent

排除标准：

排除标准
符合以下任一条标准的对象将排除于本研究:
1、目前正在使用特定的不被允许的药物
2、装有特定的装置（如心脏起博器）
3、处于怀孕或哺乳期
4、在随访期间出现新冠病毒感染或其他发热性疾病
5、在特定的时间内使用其他试验药物治疗
6、有排除于研究的指定疾病或条件（身体或心理、体检发现）
7、有严重的心、肺、肝肾功能障碍及精神障碍；
8、既往已接受肺癌相关临床治疗性干预如手术、放疗、化疗、靶向治疗、免疫治疗等
9、因取样问题，无法满足研究单位的组织病理检测要求
10、近 5 年内有恶性肿瘤史。

Exclusion criteria：

Exclusion criteria
Subjects who met any of the following criteria were excluded from this study:
1. Specific drugs that are not allowed are currently being used
2. Equipped with a specific device (e.g. cardiac pacemaker)
3. In pregnancy or lactation
4. New coronavirus infection or other febrile diseases occurred during the follow-up period
5. Treatment with other trial drugs at a specific time
6. There are specified diseases or conditions excluded from the study (physical or psychological, physical examination findings)
7. There were serious heart, lung, liver and kidney dysfunction and mental disorders;
8. In the past, we have received clinical therapeutic interventions related to lung cancer, such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
9. Because of the sampling problem, it can not meet the requirements of the Research Institute for histopathological examination
10. There was a history of malignant tumor in recent 5 years.

研究实施时间：

Study execute time：

从 From 2020-10-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-10-01 00:00:00 至 To 1990-01-01 00:00:00  

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

病理检查

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Pathological examination

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

AI影像智能分析技术、CT扫描 原位荧光杂交技术 ddPCR技术检测shox2基因甲基化

Index test:

AI image intelligent analysis technology, CT scanning In situ fluorescence hybridization Detection of Shox2 gene methylation by DDPCR

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

正常健康人群和有需求就诊的肺部小结节患者； 采取手术治疗的初次确诊肺癌患者； 采取手化疗的初次确诊肺癌患者。

例数:

Sample size:

1000

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Normal healthy population and patients with pulmonary nodules in need of treatment. First diagnosed lung cancer patients with surgical treatment. First diagnosed lung cancer patients treated with hand chemotherapy.

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属瑞金医院北院 

单位级别：

三级甲等 

Institution
hospital：

Ruijin Hospital North, Shanghai Jiaotong University, School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

CTC

指标类型：

主要指标

Outcome：

CTC

Type：

Primary indicator

测量时间点：

影像学显示肺部存在结节后

测量方法：

FISH技术

Measure time point of outcome：

After imaging showed pulmonary nodules

Measure method：

In situ fluorescence hybridization

指标中文名：

CTC

指标类型：

主要指标

Outcome：

CTC

Type：

Primary indicator

测量时间点：

治疗前

测量方法：

FISH技术

Measure time point of outcome：

Before treatment

Measure method：

Multicolor in situ fluorescence hybridization

指标中文名：

癌变情况

指标类型：

主要指标

Outcome：

Canceration

Type：

Primary indicator

测量时间点：

影像学显示肺部存在结节后

测量方法：

组织活检

Measure time point of outcome：

After imaging showed pulmonary nodules

Measure method：

Tissue biopsy

指标中文名：

SEN, SPE, ACC, AUC of ROC

指标类型：

主要指标

Outcome：

SEN, SPE, ACC, AUC of ROC

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：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

肺部组织

组织：

肺部

Sample Name：

Lung tissue

Tissue：

lung

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

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 岁 years
最大 Max age 80 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

将符合标准的入组患者按照组别不同分开编码，采取双盲法编号和实验

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

The patients who met the criteria were coded separately according to different groups, and were numbered and tested by double-blind method

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

Yes

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）：

随论文发表公开

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

Published with papers

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：

本研究的临床资料采用纸质版《病例报告表》收集信息，资料的收集与保存符合 GCP 要求。纸质版《病例报告表》由研究人员保存。录入后数据资料遵循盲法原则，由统计学负责人独立处理。 影像资料： 本研究需要收集受试者的影像学资料，包括影像资料及相关报告，所有资料以拍照文件或复印件形式，由临床研究人员在负责人监督下进行，负责人将对报告数据的准确性、完整性、及时性负责。所有数据应清晰以确保准确的解释，并保证其可溯源性。 临床数据将建立数据库保管，数据库应有密码保护，数据库建立时应设立逻辑校对程序。

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

The clinical data of this study were collected by the paper version of the case report form. The collection and preservation of the data met the requirements of GCP. The paper version of the case report form was kept by the researchers. The input data follow the principle of blind method and are processed by the person in charge of statistics independently. Image data: In this study, we need to collect the imaging data of subjects, including imaging data and related reports. All the data are in the form of photographic documents or photocopies, which are carried out by clinical researchers under the supervision of the person in charge. The person in charge will be responsible for the accuracy, completeness and timeliness of the reported data. All data should be clear to ensure accurate interpretation and traceability. The clinical data will be kept in a database, which should be protected by password, and logical proofreading program should be set up when the database is established.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-08-24 11:28:40