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THE ROLE OF Ca 19-9, Ca 72-4, CEA AND CHOLESTEROL LEVELS IN PREDICTING MALIGNANCY IN GALLBLADDER POLYPS.
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注册号：

Registration number：

 ChiCTR2100047659 

最近更新日期：

Date of Last Refreshed on：

 2022-02-27 01:22:09 

注册时间：

Date of Registration：

 2021-06-21 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

THE ROLE OF Ca 19-9, Ca 72-4, CEA AND CHOLESTEROL LEVELS IN PREDICTING MALIGNANCY IN GALLBLADDER POLYPS.

Public title：

THE ROLE OF Ca 19-9, Ca 72-4, CEA AND CHOLESTEROL LEVELS IN PREDICTING MALIGNANCY IN GALLBLADDER POLYPS.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

THE ROLE OF Ca 19-9, Ca 72-4, CEA AND CHOLESTEROL LEVELS IN PREDICTING MALIGNANCY IN GALLBLADDER POLYPS.

Scientific title：

THE ROLE OF Ca 19-9, Ca 72-4, CEA AND CHOLESTEROL LEVELS IN PREDICTING MALIGNANCY IN GALLBLADDER POLYPS.

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：

Nazmi OZER 

研究负责人：

Nazmi OZER 

Applicant：

Nazmi OZER 

Study leader：

Nazmi OZER 

申请注册联系人电话：

Applicant telephone：

 +90 50 67153570

研究负责人电话：

Study leader's
telephone：

+90 50 67153570

申请注册联系人传真 ：

Applicant Fax：

 +90 32 24559000

研究负责人传真：

Study leader's fax：

 +90 32 24559000

申请注册联系人电子邮件：

Applicant E-mail：

 nazmiozer83@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 nazmiozer83@gmail.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：

Dr. Mithat ?zsan Bulvar? K??la Mah. 4522 Sok. No:1 Yüre?ir, ADANA, TURKEY

研究负责人通讯地址：

Dr. Mithat ?zsan Bulvar? K??la Mah. 4522 Sok. No:1 Yüre?ir, ADANA, TURKEY

Applicant address：

Dr. Mithat ?zsan Bulvar? K??la Mah. 4522 Sok. No:1 Yüre?ir, ADANA, TURKEY

Study leader's address：

Dr. Mithat ?zsan Bulvar? K??la Mah. 4522 Sok. No:1 Yüre?ir, ADANA, TURKEY

申请注册联系人邮政编码：

Applicant postcode：

 01000

研究负责人邮政编码：

Study leader's postcode：

 01000

申请人所在单位：

土耳其Adana city training and research hospital General surgery department

Applicant's institution：

Adana city training and research hospital General surgery department

研究负责人所在单位：

土耳其Adana city training and research hospital General surgery department

Affiliation of the Leader：

Adana city training and research hospital General surgery department

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：

 70/1141

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：

Ethics Committee of the Adana City Training and Research Hospital

Name of the ethic committee：

This retrospective cohort study was approved by the Ethics Committee of the Adana City Training and Research Hospital (date: 18.11.2020, decision number: 70/1141).

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-11-18 00:00:00

伦理委员会联系人：

Ethics Committee of the Adana City Training and Research Hospital

Contact Name of the ethic committee：

Ethics Committee of the Adana City Training and Research Hospital

伦理委员会联系地址：

Adana city training and research hospital, Dr. Mithat ?zsan Bulvar? K??la Mah. 4522 Sok. No:1 Yüre?ir, ADANA, TURKEY

Contact Address of the ethic committee：

Adana city training and research hospital, Dr. Mithat ?zsan Bulvar? K??la Mah. 4522 Sok. No:1 Yüre?ir, ADANA, TURKEY

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +90 32 24559000

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：

Nazmi OZER

Primary sponsor：

Nazmi OZER

研究实施负责（组长）单位地址：

Dr. Mithat Özsan Bulvarı Kışla Mah. 4522 Sok. No:1 Yüreğir, ADANA, TURKEY

Primary sponsor's address：

Dr. Mithat Özsan Bulvarı Kışla Mah. 4522 Sok. No:1 Yüreğir, ADANA, TURKEY

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Writers

Source(s) of funding：

None

研究疾病：

Gallbladder polyps  

Target disease：

Gallbladder polyps

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：

 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：

To determine a new algorithm in the diagnosis and treatment of gallbladder  

Objectives of Study：

In the study, it was investigated whether the malignancy potential of gallbladder polyps is associated with tumor markers and cholesterol levels,and if so,on which values the presence of malignancy should be suspected.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Patients who were diagnosed with polyps in an external center, whose cholesterol levels and tumor markers were not tested before the operation, and who had undergone previous interventional procedures to the gallbladder were excluded from the study.

Exclusion criteria：

Patients who were diagnosed with polyps in an external center, whose cholesterol levels and tumor markers were not tested before the operation, and who had undergone previous interventional procedures to the gallbladder were excluded from the study.

研究实施时间：

Study execute time：

从 From 2020-11-18 00:00:00至 To 2020-11-18 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-12-17 00:00:00 至 To 2018-12-17 00:00:00

干预措施：

Interventions：

组别：

Gallbladder polpys

样本量：

 11

Group：

Gallbladder polpys

Sample size：

干预措施：

polyp size

干预措施代码：

Intervention：

polyp size

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 Adana 

市(区县)：

  

Country：

Turkey

Province：

Adana

City：

单位(医院)：

 Adana city training and research hospital 

单位级别：

  

Institution
hospital：

Adana city training and research hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

LDL levels

指标类型：

次要指标

Outcome：

LDL levels

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：

Blood

组织：

Sample Name：

Blood

Tissue：

not specify

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

Ninety patients (MAN/WOMAN) diagnosed with gallbladder polyp by abdominal ultrasonography between December 2017 and November 2020 were included in the study

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

Ninety patients diagnosed with gallbladder polyp by abdominal ultrasonography between December 2017 and November 2020 were included in the study, and the data of the patients were obtained retrospectively from the hospital information system and outpatient clinic files.

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：

N/A

Blinding：

N/A

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）：

December 2017 and November 2020 were included in the study

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

none

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：

the data of the patients were obtained retrospectively from the hospital information system and outpatient clinic files

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

Ninety patients diagnosed with gallbladder polyp by abdominal ultrasonography between December 2017 and November 2020 were included in the study, and the data of the patients were obtained retrospectively from the hospital information system and outpatient clinic files

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-06-21 04:49:19
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