ChiCTR2600119910 版本V1.0 版本创建时间2026/03/05 14:32:25 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：

 ChiCTR2600119910 

最近更新日期：

Date of Last Refreshed on：

 2026-03-05 14:32:00 

注册时间：

Date of Registration：

 2026-03-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Public title：

Clinicopathological and Genetic Mutations of Papillary Thyroid Carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Exploring Genetic Variants of Some Genes with Related Thyroid Cancer

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：

Rawezh Qadir M Salih 

研究负责人：

Rawezh Qadir M Salih 

Applicant：

Rawezh Qadir M Salih 

Study leader：

Rawezh Qadir M Salih 

申请注册联系人电话：

Applicant telephone：

 +964 750 109 7039

研究负责人电话：

Study leader's
telephone：

+964 750 109 7039

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：

 rawezh.mohammed@univsul.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 rawezh.mohammed@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：

Azadi street-Sulaimani-IRAQ

研究负责人通讯地址：

Azadi street-Sulaimani-IRAQ

Applicant address：

Azadi street-Sulaimani-IRAQ

Study leader's address：

Azadi street-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：

Sulaimani university

Applicant's institution：

Sulaimani university

研究负责人所在单位：

Sulaimani university

Affiliation of the Leader：

Sulaimani 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：

 352

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：

The Ethics Commite of the College of Medicine,Univeristy of sulaimani

Name of the ethic committee：

The Ethics Commite of the College of Medicine,Univeristy of sulaimani

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-23 00:00:00

伦理委员会联系人：

Hiwa Assad Abdulkareem

Contact Name of the ethic committee：

Hiwa Assad Abdulkareem

伦理委员会联系地址：

Azadi street-Sulaimani-IRAQ

Contact Address of the ethic committee：

Azadi street-Sulaimani-IRAQ

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 770 158 0087

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：

Sulaimani university

Primary sponsor：

Sulaimani university

研究实施负责（组长）单位地址：

Azadi street-Sulaimani-IRAQ

Primary sponsor's address：

Azadi street-Sulaimani-IRAQ

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

IRAQ

省(直辖市)：

Sulaymaniyah

市(区县)：

Country：

IRAQ

Province：

Sulaymaniyah

City：

单位(医院)：

Sulaimani university

具体地址：

Azadi street-Sulaimani-IRAQ

Institution
hospital：

Sulaimani university

Address：

Azadi street-Sulaimani-IRAQ

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Thyroid Cancer  

Target disease：

Thyroid Cancer

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：

1.Discover new genetic mutations or variants associated with thyroid cancer that have not been previously documented 2.Analyze Common Mutations in Thyroid Cancer-Related Genes 3.Assess the Clinical Utility of NGS in Patient Management 4.Compare Genetic Variants Across Different Populations  

Objectives of Study：

1.Discover new genetic mutations or variants associated with thyroid cancer that have not been previously documented 2.Analyze Common Mutations in Thyroid Cancer-Related Genes 3.Assess the Clinical Utility of NGS in Patient Management 4.Compare Genetic Variants Across Different Populations

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Patients were eligible for inclusion if they had a histopathologically confirmed diagnosis of PTC, underwent total thyroidectomy during the study period, and had available formalin-fixed, paraffin-embedded (FFPE) tumor tissue suitable for molecular analysis. Only cases with complete clinicopathological data, including demographic, biochemical, and tumor-related parameters, were enrolled.

Inclusion criteria

Patients were eligible for inclusion if they had a histopathologically confirmed diagnosis of PTC, underwent total thyroidectomy during the study period, and had available formalin-fixed, paraffin-embedded (FFPE) tumor tissue suitable for molecular analysis. Only cases with complete clinicopathological data, including demographic, biochemical, and tumor-related parameters, were enrolled.

排除标准：

Patients were excluded if they had any other histological type of thyroid cancer, presented with distant metastasis at the time of diagnosis, or had insufficient or poor-quality FFPE samples that failed DNA extraction or sequencing quality control. Individuals with recurrent thyroid cancer, previous thyroid surgery, radiotherapy, or systemic therapy were also excluded, as well as cases with incomplete medical records that could not be used for statistical evaluation.

Exclusion criteria：

Patients were excluded if they had any other histological type of thyroid cancer, presented with distant metastasis at the time of diagnosis, or had insufficient or poor-quality FFPE samples that failed DNA extraction or sequencing quality control. Individuals with recurrent thyroid cancer, previous thyroid surgery, radiotherapy, or systemic therapy were also excluded, as well as cases with incomplete medical records that could not be used for statistical evaluation.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2025-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-01 00:00:00 至 To 2025-02-28 00:00:00

干预措施：

Interventions：

组别：

Observation group

样本量：

 45

Group：

Observation group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 IRAQ

省(直辖市)：

 Sulaymaniyah 

市(区县)：

  

Country：

IRAQ

Province：

Sulaymaniyah

City：

单位(医院)：

 Sulaimani university 

单位级别：

 Tertiary 

Institution
hospital：

Sulaimani university

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Prevalence of BRAF mutation

指标类型：

主要指标

Outcome：

Prevalence of BRAF mutation

Type：

Primary indicator

测量时间点：

测量方法：

Next-generation sequencing (NGS)

Measure time point of outcome：

Measure method：

Next-generation sequencing (NGS)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

FFPE tumor tissue

组织：

Thyroid gland

Sample Name：

FFPE tumor tissue

Tissue：

Thyroid gland

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 岁 years
最大 Max age 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）：

None

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）：

None

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：

Clinical and laboratory data will be recorded in standardized case report forms and entered into an electronic database. Data quality will be checked regularly, and patient identifiers will be removed to maintain confidentiality. Access to the dataset will be restricted to the research team.

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

Clinical and laboratory data will be recorded in standardized case report forms and entered into an electronic database. Data quality will be checked regularly, and patient identifiers will be removed to maintain confidentiality. Access to the dataset will be restricted to the research team.

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：

  2026-03-05 14:32:00