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。

Understanding the Genetic and Biological Factors That Influence Cancer Treatment Response and Resistance in Patients With Advanced Solid Tumours Through Sample Analysis (MC2)

Understanding the Molecular Pathways Underlying Drug Response and Resistance in Early Clinical Trials Through Tumour Molecular Characterisation

The goal of this observational study is to attempt to find altered genetic 'switches' (mutations) in adults with advanced solid cancers who are being considered for, or are participating in, early-phase cancer clinical trials. Research has shown that cancer cells make use of key mutations to 'switch on' their growth, spread, and survival. This study will use this information to evaluate what happens to mutations over time which may help match patients to suitable clinical trials and support the development of more personalised cancer treatments. The main question it aims to answer is: Can mutations identified in various samples, including tumour samples and blood samples, help predict which patients are most likely to benefit from specific cancer treatments or clinical trials? Participants will provide consent to allow previously collected tumour samples, such as tissue from earlier biopsies or surgery, to be used for molecular analysis; allow researchers to collect and analyse clinical information about their cancer, treatments, clinical trial participation, and outcomes; be asked to provide optional research samples, which may include blood, urine, saliva, stool samples, cheek swabs, rectal swabs, tumour biopsies, and other bodily fluids when clinically appropriate; have tumour and other samples analysed to identify genetic and molecular changes that may influence cancer growth, treatment response, and treatment resistance; be informed if clinically significant findings are identified that may be relevant to their cancer care; and be followed over time through review of medical records to monitor clinical outcomes and the safety of research sample collection procedures, including biopsies. This study does not test a specific treatment. Information gained from the study may help researchers better understand cancer biology, identify new treatment targets, improve patient selection for future clinical trials, and support the development of personalised cancer therapies.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

5000

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

  • 姓名:Jessica Maudsley
  • 电话号码:+44 20 3437 6017
  • 邮箱:MC2@icr.ac.uk

研究联系人备份

  • 姓名:Bindu Baikady
  • 电话号码:02034376033
  • 邮箱:MC2@icr.ac.uk

学习地点

      • Sutton、英国、SM2 5PT
        • 招聘中
        • Royal Marsden NHS Foundation Trust - Drug Development Unit
        • 首席研究员:
          • Professor Johann de Bono
        • 接触:
          • Professor Johann de Bono
          • 电话号码:02087224028
      • Sutton、英国、SM2 5PT
        • 招聘中
        • Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
        • 首席研究员:
          • Professor Johann de Bono
        • 接触:
          • Professor Johann de Bono
          • 电话号码:02087224028

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with advanced solid cancers who are considered eligible for clinical trials based on best medical practices in oncology.

描述

Inclusion Criteria:

  1. Histologically, cytologically or biochemically confirmed diagnosis of advanced solid cancer
  2. Older than or equal to 18 years of age
  3. Patients who are being considered for an early phase clinical trial or who are currently participating in an early phase clinical trial
  4. Written (signed and dated) informed consent.

Exclusion Criteria:

N/A.

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
Patients with progressing advanced solid cancers.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To facilitate basic and translational research that includes the correlation of molecular abnormalities with corresponding trial participation and survival data, in order to develop and apply biomarkers for personalised medicine
大体时间:15 years
15 years

次要结果测量

结果测量
大体时间
To identify molecular mechanisms that allow for exceptional response in our clinical trials by detailed analysis of samples from exceptional responders to generate hypotheses for future drug development.
大体时间:15 years
15 years
To offer advanced cancer patients next generation sequencing (NGS) and/or immunohistochemistry (IHC) and other biomarker analysis of tumour tissue and/or blood samples
大体时间:15 years
15 years
To prospectively collect ongoing data on the safety of collection of fresh tissue from research participants and report on serious medically significant events
大体时间:15 years
15 years

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。

调查人员

  • 研究主任:Professor Johann de Bono、Institute of Cancer Research, United Kingdom

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4月28日

初级完成 (估计的)

2036年6月1日

研究完成 (估计的)

2036年6月1日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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.

订阅