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Clinical Trials/NCT06086574
NCT06086574
Recruiting
Not Applicable

Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

University of Manchester1 site in 1 country80 target enrollmentMarch 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer Stage III
Sponsor
University of Manchester
Enrollment
80
Locations
1
Primary Endpoint
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.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2023
End Date
September 24, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

CFaivreFinn

Professor Corinne Faivre-Finn

University of Manchester

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 2.5 years

Secondary Outcomes

  • 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)

Study Sites (1)

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