ChiCTR2200056193 版本V1.0 版本创建时间2024/08/11 23:05:35 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：

 ChiCTR2200056193 

最近更新日期：

Date of Last Refreshed on：

 2022-02-01 12:57:02 

注册时间：

Date of Registration：

 2022-02-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Hiwa omer: please submit the approval letter of IRB

Public title：

Sonographic Measurement of Splenic Size and its Correlation with Body Parameters in Kurdish Population

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Sonographic Measurement of Splenic Size and its Correlation with Body Parameters in Kurdish Population

Scientific title：

Sonographic Measurement of Splenic Size and its Correlation with Body Parameters in Kurdish Population

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：

Hiwa omer 

研究负责人：

Fahmi Hussien 

Applicant：

Hiwa omer 

Study leader：

Fahmi Hussien 

申请注册联系人电话：

Applicant telephone：

 +96 47501063666

研究负责人电话：

Study leader's
telephone：

+96 47717267454

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：

 premierfanb@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 fahmi.hussein@univsul.edu.iq

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：

medical school, Faculty of Medical Science, University of Sulaimani, Iraq

研究负责人通讯地址：

medical school, Faculty of Medical Science, University of Sulaimani, Iraq

Applicant address：

medical school, Faculty of Medical Science, University of Sulaimani, Iraq

Study leader's address：

medical school, Faculty of Medical Science, University of Sulaimani, Iraq

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：

伊拉克苏莱曼尼大学

Applicant's institution：

Smart health tower, Sulaimani University, Iraq

研究负责人所在单位：

伊拉克苏莱曼尼大学

Affiliation of the Leader：

Smart health tower, Sulaimani University, Iraq

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：

 N/A

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：

ethical committee of medical school, Faculty of Medical Science, University of Sulaimani

Name of the ethic committee：

ethical committee of medical school, Faculty of Medical Science, University of Sulaimani

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

ethical committee of medical school, Faculty of Medical Science, University of Sulaimani

Contact Name of the ethic committee：

ethical committee of medical school, Faculty of Medical Science, University of Sulaimani

伦理委员会联系地址：

sulaimani, kurdistan region -Iraq

Contact Address of the ethic committee：

sulaimani, kurdistan region -Iraq

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：

medical school, Faculty of Medical Science, University of Sulaimani

Primary sponsor：

medical school, Faculty of Medical Science, University of Sulaimani

研究实施负责（组长）单位地址：

medical school, Faculty of Medical Science, University of Sulaimani

Primary sponsor's address：

medical school, Faculty of Medical Science, University of Sulaimani

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

伊拉克

省(直辖市)：

苏莱曼尼

市(区县)：

Country：

Iraq

Province：

Sulaimani

City：

Sulaimani

单位(医院)：

Smart health tower

具体地址：

Sulaimani, Kurdistan region-Iraq

Institution
hospital：

Smart health tower

Address：

Sulaimani, Kurdistan region-Iraq

经费或物资来源：

All funding was covered by authors.

Source(s) of funding：

All funding was covered by authors.

研究疾病：

N/A  

Target disease：

N/A

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：

连续入组 

Study design：

Sequential 

研究目的：

This study aims to establish reference value of splenic dimensions, volume and its correlation to the different body parameters in Kurdish population  

Objectives of Study：

This study aims to establish reference value of splenic dimensions, volume and its correlation to the different body parameters in Kurdish population

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Normal healthy Kurdish adult male and female population in Sulaimani region who had normal complete blood count (CBC)

Inclusion criteria

Normal healthy Kurdish adult male and female population in Sulaimani region who had normal complete blood count (CBC)

排除标准：

Subjects in this study will fill a short-standardized interview questionnaire to exclude any previous or current conditions that might involve the size of the spleen & exclusion criteria were include:
1. Subjects with age younger than 20 years.
2. Clinical or laboratory evidence of infection or jaundice either at the time of the examination or within at least 6 weeks prior to the examination)
3. History of Rheumatoid disease
4. Anemia or haemoglobinopathies (thalassemia and sickle cell anemia).
5. Subjects with Hx of lymphoproliferative disorders or Myeloproliferative neoplasm
6. Subjects in whom the entire length of the spleen could not be properly documented by US or sonographically detectable focal spleen lesions.
7. History of splenic trauma& or those with partial splenectomy.
8. Liver diseases (cirrhosis or portal hypertension).
9. Gravid women.
10. Non-Kurdish races.

Exclusion criteria：

Subjects in this study will fill a short-standardized interview questionnaire to exclude any previous or current conditions that might involve the size of the spleen & exclusion criteria were include:
1. Subjects with age younger than 20 years.
2. Clinical or laboratory evidence of infection or jaundice either at the time of the examination or within at least 6 weeks prior to the examination)
3. History of Rheumatoid disease
4. Anemia or haemoglobinopathies (thalassemia and sickle cell anemia).
5. Subjects with Hx of lymphoproliferative disorders or Myeloproliferative neoplasm
6. Subjects in whom the entire length of the spleen could not be properly documented by US or sonographically detectable focal spleen lesions.
7. History of splenic trauma& or those with partial splenectomy.
8. Liver diseases (cirrhosis or portal hypertension).
9. Gravid women.
10. Non-Kurdish races.

研究实施时间：

Study execute time：

从 From 2020-08-07 00:00:00至 To 2021-03-05 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-09-27 00:00:00 至 To 2021-09-30 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 300

Group：

Case series

Sample size：

干预措施：

No

干预措施代码：

Intervention：

No

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 伊拉克

省(直辖市)：

 苏莱曼尼 

市(区县)：

  

Country：

Iraq

Province：

Sulaimani

City：

单位(医院)：

  

单位级别：

  

Institution
hospital：

Level of the institution：

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Positive

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：

No

组织：

Sample Name：

No

Tissue：

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 20 岁 years
最大 Max age 87 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）：

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：

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）：

N/A

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

N/A

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

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

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-02-01 12:57:02