Clinical trial NCT06086574: Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer
Official title: Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Stage III
Keywords: Non small cell lung cancer
NSCLC
Stage III
Radiotherapy
Biomarker
Circulating-tumour DNA
Radiomics
PROM
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2023-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated under The Christie NHS Foundation Trust, Greater 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.


Eligibility criteria: Inclusion criteria:

* Histological or cytologically confirmed NSCLC.
* Unsuitable for surgery due to tumour or patient factors.
* Stage 3 A, B or C (TNM version 8).
* Planned to receive radical radiotherapy OR sequential chemoradiotherapy OR concurrent chemoradiotherapy +/- consolidation immunotherapy.
* Predicted life expectancy \>12 weeks.
* Ability to provide written informed consent.
* Willingness to comply with study procedures.

Exclusion criteria:

* Mixed non-small cell and small cell tumours.
* Adjuvant radiotherapy post-surgery.
* Participation in a study of an interventional study as part of lung cancer treatment.
* Recent/active malignant disease which might impact study results.
* Psychotic disorders/cognitive impairment.

Primary outcomes:
measure: 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.
timeFrame: 2.5 years
Secondary outcomes:
measure: Longitudinal description of circulating-tumour DNA patterns at baseline, during and for up to 1 year following completion of radiotherapy.
timeFrame: 2.5 years
measure: Longitudinal description of radiomic features at baseline, during and for up to 1 year following completion of radiotherapy.
timeFrame: 2.5 years
measure: Longitudinal description of patient reported outcomes at baseline, during and for up to 1 year following completion of radiotherapy.
timeFrame: 2.5 years
measure: Predictive model built using baseline and longitudinal circulating-tumour DNA and radiomic features to predict benefit from consolidation immunotherapy.
timeFrame: 2.5 years
measure: Associations between features and changes in features over time will be described, e.g. radiomic features associated with circulating-tumour DNA and radiomic features.
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: