ChiCTR2000039965 版本V1.2 版本创建时间2021/02/22 01:06:25 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：

 ChiCTR2000039965 

最近更新日期：

Date of Last Refreshed on：

 2021-02-22 01:05:59 

注册时间：

Date of Registration：

 2020-11-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Please upload approved file of ethical committee. Dual Spectroscopic Assessment (DSA) on tumor margin of breast cancer during breast conserving surgery with Near infrared (NIR) and Raman spectroscopy: a novel intraoperative ma

Public title：

Dual Spectroscopic Assessment (DSA) on tumor margin of breast cancer during breast conserving surgery with Near infrared (NIR) and Raman spectroscopy: a novel intraoperative margin assessment device

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Dual Spectroscopic Assessment (DSA) on tumor margin of breast cancer during breast conserving surgery with Near infrared (NIR) and Raman spectroscopy: A novel intraoperative margin assessment devic

Scientific title：

Dual Spectroscopic Assessment (DSA) on tumor margin of breast cancer during breast conserving surgery with Near infrared (NIR) and Raman spectroscopy: A novel intraoperative margin assessment device

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：

Hung Ka Wai Ray 

研究负责人：

Hung Ka Wai Ray 

Applicant：

Hung Ka Wai Ray 

Study leader：

HUNG KA WAI RAY 

申请注册联系人电话：

Applicant telephone：

 +852 91616765

研究负责人电话：

Study leader's
telephone：

+852 91616765

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：

 hkw879@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 hkw879@ha.org.hk

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：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong SAR, China

研究负责人通讯地址：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong SAR, China

Applicant address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong SAR, China

Study leader's address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong SAR, 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：

香港醫院管理局

Applicant's institution：

Hospital Authority

研究负责人所在单位：

香港醫院管理局

Affiliation of the Leader：

Hospital Authority

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：

 2020.421

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint CUHK-NTEC CREC

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-04-21 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong, 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：

N/A

Primary sponsor：

N/A

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

N/A

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

NA

研究疾病：

乳腺癌  

Target disease：

breast cancer

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

This is a pilot study aimed to establish a reference data set containing the typical characteristic of tumor margin of breast cancer by using Raman and near infrared spectroscopy.  

Objectives of Study：

This is a pilot study aimed to establish a reference data set containing the typical characteristic of tumor margin of breast cancer by using Raman and near infrared spectroscopy.

药物成份或治疗方案详述：

Patients with breast cancer planning for surgery will be recruited. After completing the surgery, 1 core of normal breast tissue and 1 core of the tumor from the surgical specimen will be taken by a core biopsy needle and stored in a bottle containing formalin solution. The specimens will be sent to The Hong Kong University of Science and Technology for spectroscopic assessment. Research-level Raman spectroscopy and NIR spectroscopy will be used to characterize the specimens obtained from 10 patients. The dual spectroscopic information will be combined to build an initial fitting algorithm. This fitting algorithm will be used in subsequent studies for assessing specimen of unknown characteristic and the result will be validated by standard pathological analysis. 

Description for medicine or protocol of treatment in detail：

Patients with breast cancer planning for surgery will be recruited. After completing the surgery, 1 core of normal breast tissue and 1 core of the tumor from the surgical specimen will be taken by a core biopsy needle and stored in a bottle containing formalin solution. The specimens will be sent to The Hong Kong University of Science and Technology for spectroscopic assessment. Research-level Raman spectroscopy and NIR spectroscopy will be used to characterize the specimens obtained from 10 patients. The dual spectroscopic information will be combined to build an initial fitting algorithm. This fitting algorithm will be used in subsequent studies for assessing specimen of unknown characteristic and the result will be validated by standard pathological analysis. 

纳入标准：

Breast cancer patient.

Inclusion criteria

Breast cancer patient.

排除标准：

Received upfront chemotherapy.

Exclusion criteria：

Received upfront chemotherapy.

研究实施时间：

Study execute time：

从 From 2020-11-02 00:00:00至 To 2020-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-11-02 00:00:00 至 To 2020-11-30 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）：

pathological assessment using light microscopy

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 assessment using light microscopy

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）：

Raman and near infrared spectroscopy

Index test:

Raman and near infrared spectroscopy

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）

breast cancer patient

例数:

Sample size:

10

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):

breast cancer patient

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：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 北區醫院 

单位级别：

 北區醫院 

Institution
hospital：

North District Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Spectroscopy of normal breast tissue and breast cancer tissue

指标类型：

主要指标

Outcome：

Spectroscopy of normal breast tissue and breast cancer tissue

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：

core biopsy tissue from normal breast and cancer

组织：

breast

Sample Name：

core biopsy tissue from normal breast and cancer

Tissue：

breast

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 岁 years
最大 Max age 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

N/A

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：

Not stated

Blinding：

Not stated

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）：

Not stated 请阅读网页注册指南中关于“原始数据共享”的内容。

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

Not stated

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：

N/A 请阅读网页注册指南中关于 数据收集和管理系统 的内容。

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

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-11-15 08:11:39