此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Muscle Dysfunction in Patients With Haematological Diseases

2021年12月3日 更新者：Jan Christensen、Rigshospitalet, Denmark

The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.

PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

研究概览

地位

招聘中

条件

详细说明

Some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. It is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

研究类型

观察性的

注册 (预期的)

216

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 丹麦
      • Copenhagen、丹麦
        • 招聘中
        • Rigshospitalet
        • 接触：
        • 接触：
        • 首席研究员：
          • Charlotte Noerregaard Groenset, MSc

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.

描述

Inclusion Criteria:

• Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.

Exclusion Criteria:

  • Age: <18
  • Pregnancy
  • Physical or mental disabilities precluding test of muscle function
  • Inability to read and understand Danish.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Cohort I - Patients newly diagnosed with malignant lymphoma (n=72)
These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start
Cohort II - Patients newly diagnosed with acute leukaemia (n=72)
These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start
Cohort III - Patients newly diagnosed with multiple myeloma (n=72)
These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Whole body Lean body Mass
大体时间：Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start

次要结果测量

结果测量
措施说明
大体时间
Hospitalization duration
大体时间：1 year post treatment
Total number days in hospital
1 year post treatment
Disease free survival
大体时间：1 year post treatment
Risk of disease progression
1 year post treatment
Overall survival
大体时间：1 year post treatment
Risk of mortality from any-cause
1 year post treatment
Change in appendicular lean mass
大体时间：Baseline and 6 after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 after treatment start
Change in whole body fat percentage
大体时间：Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in visceral fat mass
大体时间：Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in bone mineral density
大体时间：Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in bone mineral content
大体时间：Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in walking capacity
大体时间：Baseline and 6 months after treatment start
Maximum 10 meter walking speed
Baseline and 6 months after treatment start
Change in lower body physical function
大体时间：Baseline and 6 months after treatment start
30 seconds Sit-To-Stand test
Baseline and 6 months after treatment start
Change in maximum leg power
大体时间：Baseline and 6 months after treatment start
Leg extensor power test (Nottingham Power Rig)
Baseline and 6 months after treatment start
Change in hand grip strength
大体时间：Baseline and 6 months after treatment start
Maximum strength test by handgrip dynamometer
Baseline and 6 months after treatment start
Change in inflammation markers
大体时间：Baseline and 6 months after treatment start
Blood values are registered from the patients hospital record in relation to assessments. C-reactive protein (CRP) and leucocytes are registered as they are inflammation markers.
Baseline and 6 months after treatment start
Change in creatinine
大体时间：Baseline and 6 months after treatment start
Blood values are registered from the patients hospital record in relation to assessments. Creatinine is registered due to their relation to muscle strength..
Baseline and 6 months after treatment start
Change in hemoglobin
大体时间：Baseline and 6 months after treatment start
Blood values are registered from the patients hospital record in relation to assessments. Hemoglobin is registered due to their relation to muscle strength.
Baseline and 6 months after treatment start
Change in body fat percentage
大体时间：Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in fat mass
大体时间：Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in fat-free mass
大体时间：Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in muscle mass
大体时间：Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in bone mass
大体时间：Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in total body water
大体时间：Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in health-related quality of life
大体时间：Baseline and 6 months after treatment start
European Organisation for Research and Treatment of Cancer Quality of LifeQuestionnaire, Version 3.0 Scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Baseline and 6 months after treatment start
Change in physical activity level
大体时间：Baseline and 6 months after treatment start
The International Physical Activity Questionnaires, short form. The Questionnaires covers the frequency and duration of vigorous, moderate, and walking activities over the last 7 days, as well as a single-item question on weekday sitting. Using the instrument's scoring protocol, total weekly physical activity can be calculated to three levels of physical activity and the interpretation of the questionnaire can be categorized in low, moderate and high physical activity, based on the stated time and Metabolic Equivalent of Task (METs min/week) used in different types of activities.
Baseline and 6 months after treatment start

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Rigshospitalet, Denmark

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月8日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2023年12月31日

研究注册日期

首次提交

2021年11月8日

首先提交符合 QC 标准的

2021年12月3日

首次发布 (实际的)

2021年12月9日

研究记录更新

最后更新发布 (实际的)

2021年12月9日

上次提交的符合 QC 标准的更新

2021年12月3日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MuscleLab2020

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Not provided

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Burundi

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅