Today is 2020-08-05

A prospective, single-center, observational study of the effect of chemotherapy on bone health in adult lymphoma patients
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注册号:

Registration number:

ChiCTR2000034088 

最近更新日期:

Date of Last Refreshed on:

2020-06-28 

注册时间:

Date of Registration:

2020-06-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

化疗对成人淋巴瘤患者骨骼健康影响的单中心、前瞻性、观察性研究 

Public title:

A prospective, single-center, observational study of the effect of chemotherapy on bone health in adult lymphoma patients 

注册题目简写:

BONE-LIN01 

English Acronym:

BONE-LIN01 

研究课题的正式科学名称:

淋巴瘤患者骨健康的前瞻性观察性研究 

Scientific title:

A prospective observational study of bone health in patients with lymphoma 

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:

何静松 

研究负责人:

何静松 

Applicant:

Jingsong He 

Study leader:

Jingsong He 

申请注册联系人电话:

Applicant telephone:

+86 13600547247 

研究负责人电话:

Study leader's telephone:

+86 13600547247 

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:

hejingsong@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

hejingsong@zju.edu.cn 

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:

浙江杭州上城区城站路58号2号楼4楼 

研究负责人通讯地址:

浙江杭州上城区城站路58号2号楼4楼 

Applicant address:

Fourth Floor, Building 2, 58 Chengzhan Road, Shangcheng District, Hangzhou, Zhejiang, China 

Study leader's address:

Fourth Floor, Building 2, 58 Chengzhan Road, Shangcheng District, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310006 

研究负责人邮政编码:

Study leader's postcode:

310006 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Zhejiang University Medical College 

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)IIT快审第(222)号) 

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:

浙江大学医学院附属第一医院临床研究伦理委员会IIT伦理审查小组 

Name of the ethic committee:

Clinical Research Ethics Committee of The First Affiliated Hospital, College of Medicine,Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-28 

伦理委员会联系人:

蒋怡雅 

Contact Name of the ethic committee:

Yiya Jiang 

伦理委员会联系地址:

浙江杭州上城区庆春路79号17号楼3楼 

Contact Address of the ethic committee:

Third Floor, Building 17, 79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University Medical College 

研究实施负责(组长)单位地址:

浙江杭州上城区庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

上城区庆春路79号

Institution
hospital:

The First Affiliated Hospital of Zhejiang University Medical College

Address:

79 Qingchun Road, Shangcheng District

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

淋巴瘤 

Target disease:

lymphoma 

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 

研究目的:

在中国淋巴瘤人群中评估化疗对新诊断淋巴瘤患者骨密度以及骨代谢的影响。 

Objectives of Study:

To evaluate the effect of chemotherapy on bone mineral density and bone metabolism in newly diagnosed lymphoma patients in Chinese populations. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

≥18岁~75岁; 新诊断的淋巴瘤并需要治疗的患者,或者之前疾病评估无需治疗而最近疾病进展而需要治疗的患者; 患者需接受至少4疗程的单药或者联合化疗, 可接受利妥昔单抗单药或者激酶小分子抑制剂的单药治疗的患者,加或不加放疗。 

Inclusion criteria

1. Aged 18 to 75 years old patients; 2. Patients with newly diagnosed lymphoma who need to be treated, or patients who need to be treated due to the recent disease progress without treatment due to previous disease assessment; 3. Patients who need at least 4 courses of single or combined chemotherapy; 4. Patients who can be treated with rituximab or single drug of small molecule kinase inhibitor, with or without radiotherapy. 

排除标准:

存在已知的骨代谢疾病导致的骨质疏松病或骨质疏松性骨折病史, 曾经或现诊断为除淋巴瘤外的其他恶性肿瘤;存在已控制和/或尚未控制的内分泌问题(主要或继发性甲状旁腺功能亢进症),代谢性骨疾病(即Paget病); 肌酐清除率<60 ml / min,考虑为淋巴瘤导致,并在治疗后恢复的患者可以接受; 既往有长期糖皮质激素治疗史; 既往有腰椎部位放疗史; 淋巴瘤累及腰椎或髋关节。 

Exclusion criteria:

1. Patients with known history of osteoporosis or osteoporotic fracture caused by bone metabolism disease; 2. Patients who have been or are diagnosed with other malignant tumors except lymphoma; 3. Patients with controlled and / or uncontrolled endocrine problems (primary or secondary hyperparathyroidism), metabolic bone disease (Paget disease); 4. The clearance rate of creatinine is less than 60 ml / min, which is considered to be caused by lymphoma and can be accepted by patients who recover after treatment; 5. Patients with a long history of glucocorticoid therapy; 6. Patients with previous history of lumbar radiotherapy; 7. Patients with lymphoma involving lumbar or hip joint. 

研究实施时间:

Study execute time:

From2020-07-01To 2026-06-30 

征募观察对象时间:

Recruiting time:

From2020-07-01To 2021-06-30 

干预措施:

Interventions:

组别:

初治淋巴瘤患者

样本量:

69

Group:

Case series

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospitall, College of Medicine, Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

骨密度

指标类型:

主要指标 

Outcome:

Bone density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨代谢相关因子

指标类型:

主要指标 

Outcome:

Bone metabolism related factors

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

QoL

指标类型:

次要指标 

Outcome:

QoL

Type:

Secondary indicator 

测量时间点:

测量方法:

FACT-Lym and EQ-5D-5L

Measure time point of outcome:

Measure method:

FACT-Lym and EQ-5D-5L

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 75 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):

NA

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

http://www.medresman.org

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

http://www.medresman.org

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-06-23
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