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Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)

2015年2月3日 更新者：Rebecca Robinson、The Christie NHS Foundation Trust

Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.

This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.

研究概览

地位

暂停

条件

干预/治疗

研究类型

观察性的

注册 (预期的)

50

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。

学习地点

  • 英国
      • Manchester、英国、M20 4BX
        • The Christie NHS Foundation Trust

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 with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.

描述

Inclusion Criteria:

  • Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
  • Age 18 or older
  • Performance Status 0-2
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.

Exclusion Criteria:

  • Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
  • Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
  • Radio-immunotherapy within the last 8 weeks.
  • Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

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
干预/治疗
Biomarker and health economics
Biomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.
程序：Biomarker and health economics
Biomarkers CK18 and FLT3 Ligand will be collected

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
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
大体时间：day 3
to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
day 3

次要结果测量

结果测量
大体时间
number of hospital admissions for febrile neutropenia
大体时间：end of chemotherapy at approximately 6 months
end of chemotherapy at approximately 6 months
Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
大体时间：End of study chemotherapy at approximately 6 months
End of study chemotherapy at approximately 6 months
Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
大体时间：End of chemotherapy at approximately 6 months
End of chemotherapy at approximately 6 months
Number of total days delay in receiving chemotherapy treatment compared to planned delivery
大体时间：end of chemotherapy at approximately 6 months
end of chemotherapy at approximately 6 months
Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires
大体时间：cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors
大体时间：end of study chemotherapy at approximately 6 months
end of study chemotherapy at approximately 6 months

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

The Christie NHS Foundation Trust

调查人员

  • 学习椅：Alastair Greystoke、The Christie NHS Foundation Trust

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

2013年10月1日

初级完成 (预期的)

2015年11月1日

研究注册日期

首次提交

2013年8月9日

首先提交符合 QC 标准的

2013年8月12日

首次发布 (估计)

2013年8月14日

研究记录更新

最后更新发布 (估计)

2015年2月4日

上次提交的符合 QC 标准的更新

2015年2月3日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 11_DOG05_99

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.

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