ChiCTR1900024075 版本V1.0 版本创建时间2019/7/1 11:02:46 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:

ChiCTR1900024075 

最近更新时间:

Date of Last Refreshed on:

2019/6/24 19:54:36 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

宋扬医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 放化疗联合非血缘脐带血移植治疗儿童神经肿瘤的前瞻性研究 

Public title:

Prospective study for chemoradiotherapy combined with unrelated donor umbilical cord blood transplantation for childhood neuroma 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

放化疗联合非血缘脐带血移植治疗儿童神经肿瘤的前瞻性研究 

Scientific title:

Prospective study for chemoradiotherapy combined with unrelated donor umbilical cord blood transplantation for childhood neuroma 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

宋扬 

研究负责人:

耿明英 

Applicant:

Yang Song 

Study leader:

Mingying Geng 

申请注册联系人电话:

Applicant telephone:

+86 18323191662 

研究负责人电话:

Study leader's telephone:

+86 13708371600 

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:

songyang84zhu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

380904661@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.dph-fsi.com/ 

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:

重庆市渝中区大坪长江支路10号 

研究负责人通讯地址:

重庆市渝中区大坪长江支路10号 

Applicant address:

10 Daping Changjiang Branch Road, Yuzhong District, Chongqing 

Study leader's address:

10 Daping Changjiang Branch Road, Yuzhong District, Chongqing 

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:

陆军军医大学第三附属医院(大坪医院) 

Applicant's institution:

Third Affiliated Hospital of the Army Military Medical University (Daping Hospital) 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

陆军军医大学第三附属医院(大坪医院) 

Primary sponsor:

Third Affiliated Hospital of the Army Military Medical University (Daping Hospital) 

研究实施负责(组长)单位地址:

重庆市渝中区大坪长江支路10号 

Primary sponsor's address:

10 Daping Changjiang Branch Road, Yuzhong District, Chongqing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第三附属医院(大坪医院)

具体地址:

重庆市渝中区大坪长江支路10号

Institution
hospital:

Third Affiliated Hospital of the Army Military Medical University (Daping Hospital)

Address:

10 Daping Changjiang Branch Road, Yuzhong District

经费或物资来源:

中国红十字会 

Source(s) of funding:

Red Cross Society of China 

研究疾病:

神经肿瘤 

Target disease:

Neuroma 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评价非血缘脐带血结合放化疗方案治疗儿童神经肿瘤的安全性和有效性,探究脐带血治疗儿童神经肿瘤的最佳治疗方案。 

Objectives of Study:

To evaluate the safety and effectiveness of unrelated donor umbilical cord blood combined with radiotherapy and chemotherapy in the treatment of childhood neuroma and explore the best treatment strategy of childhood neuroma with umbilical cord blood.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1 年龄6岁-18周岁; 2 所有病例经手术或活检组织学证实(儿童肿瘤诊断金标准); 3 HIV病毒阴性; 4 肝肾功能无明显异常:ALT、AST≤2.5倍的正常上限,血清Cr及BUN≤1.25倍的正常上限; 5 愿意并遵守治疗计划,按要求进行随访及实验室检测; 6 获得患者或家属签署的知情同意书。 

Inclusion criteria

1. Aged 6 to 18 years; 2. All cases were histologically confirmed by surgery or biopsy (gold standard for diagnosis of childhood tumors); 3. HIV virus is negative; 4. There is no obvious abnormality in liver and kidney function: ALT, AST ≤ 2.5 times of normal upper limit, serum Cr and BUN ≤ 1.25 times of normal upper limit; 5. Willing to follow the treatment plan, follow-up and laboratory testing as required; 6. Obtain informed consent signed by the patient or family member. 

排除标准:

1 有其他先天性或免疫性病史; 2.有严重精神疾病及认知功能障碍; 3.对生物制剂严重过敏; 4.对化疗药存在明显禁忌; 5.严重心脏病,包括心肌梗塞、心功能不全; 6.研究者认为患者不宜参加本研究的任何其他情况。 

Exclusion criteria:

1. With other history of congenital or immune disease; 2. Severe mental illness and cognitive impairment; 3. Severe allergies to biological agents; 4. There are obvious taboos on chemotherapeutic drugs; 5. Severe heart diseases, including myocardial infarction and cardiac insufficiency; 6. Any other situations in which researchers believe that patients should not participate in the this study.  

研究实施时间:

Study execute time:

From2019-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

非血缘脐带血输注

干预措施代码:

Intervention:

unrelated cord blood transfusion

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规放化疗

干预措施代码:

Intervention:

Conventional radiotherapy and chemotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学第三附属医院(大坪医院) 

单位级别:

三级甲等 

Institution
hospital:

Third Affiliated Hospital of the Army Military Medical University (Daping Hospital)  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

无进展生存时间

指标类型:

主要指标 

Outcome:

Progression-free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

客观缓解率

指标类型:

主要指标 

Outcome:

Objective remission rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

次要指标 

Outcome:

Quality of life score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

毒副作用

指标类型:

次要指标 

Outcome:

Toxic side reaction

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:

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:

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 3 years
最大 Max age 18 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):

随机方法:采用区组随机化方法分配序列 宋扬医师:请补充说明何人使用何种方法(统计学软件?随机数字表?或其他方法)产生随机序列。

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

The allocation sequence was generated by block randomisation

UTN(全球唯一识别码):

盲法:

open

Blinding:

open

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

试验完成6个月内 请说明共享方式

Data management Institution:

Within six months after the trial complete

资料分析单位:

病例记录表

Data analysis Institution:

Case Record Form

注册人:

Name on Registration:

 2019-06-24