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临床试验/NCT06086574
NCT06086574招募中不适用

Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

University of Manchester1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Prognostic model built using baseline and longitudinal circulating-tumour DNA, radiomic features and patient reported measures to predict survival, tumour control and early tumour relapse.

研究概览

简要总结

In stage 3 NSCLC, treatment and follow-up are generally performed in a 'one-size-fits-all' manner. In the setting of metastatic lung cancer there has been considerable success identifying biomarkers, which allow treatments to be tailored and lead to more personalised medicine. In patients with stage 3 disease there exists a significant unmet clinical need for equivalent biomarkers to guide treatment decisions such as to identify poor responders, predict benefit from treatment and diagnose relapse before standard of care imaging. Recent advances have made it possible to detect and quantify circulating-tumour DNA in peripheral blood of patients with stage 3 NSCLC, a promising prognostic biomarker and a measure of minimal residual disease. In addition, the information contained in routine medical images and electronic patient reported outcome measure (ePROM) questionnaires can add further predictive power to circulating tumour DNA and other clinical factors to determine patient's outcome. There is scope to integrate biomarkers in treatment decision algorithms aiming to make personalised treatment modifications (e.g. decision to treat with immunotherapy or not). VIGILANCE is a highly exploratory observational study to understand how these biomarkers might inform a future hypothesis driven interventional study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prognostic model built using baseline and longitudinal circulating-tumour DNA, radiomic features and patient reported measures to predict survival, tumour control and early tumour relapse.

时间窗: 2.5 years

次要结局

  • Longitudinal description of patient reported outcomes at baseline, during and for up to 1 year following completion of radiotherapy.(2.5 years)
  • Longitudinal description of circulating-tumour DNA patterns at baseline, during and for up to 1 year following completion of radiotherapy.(2.5 years)
  • Longitudinal description of radiomic features at baseline, during and for up to 1 year following completion of radiotherapy.(2.5 years)
  • Predictive model built using baseline and longitudinal circulating-tumour DNA and radiomic features to predict benefit from consolidation immunotherapy.(2.5 years)
  • Associations between features and changes in features over time will be described, e.g. radiomic features associated with circulating-tumour DNA and radiomic features.(2.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CFaivreFinn

Professor Corinne Faivre-Finn

University of Manchester

研究点 (1)

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