Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Recruiting

• Conditions: Lung Cancer Stage III

• Registration Number: NCT06086574
• Lead Sponsor: University of Manchester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-24
• Study First Submitted: 2023-09-28
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-09-24
• Study Completion: 2025-09-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2.5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom