Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer (VIGILANCE)

October 10, 2023 updated by: CFaivreFinn, University of Manchester
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated under The Christie NHS Foundation Trust, Greater Manchester

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients diagnosed with stage 3 NSCLC

Patients will receive standard of care curative-intent radiotherapy treatment as decided by their primary oncologist. This includes radical radiotherapy, sequential chemoradiotherapy and concurrent chemoradiotherapy +/- consolidation immunotherapy.

No changes in treatment. Patients will have data collected at baseline, during radiotherapy and for one year following radiotherapy. This longitudinal collection will include blood for circulating-tumour DNA analysis, electronic PROMS and radiomic analysis of standard of care imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Longitudinal description of circulating-tumour DNA patterns at baseline, during and for up to 1 year following completion of radiotherapy.
Time Frame: 2.5 years
2.5 years
Longitudinal description of radiomic features at baseline, during and for up to 1 year following completion of radiotherapy.
Time Frame: 2.5 years
2.5 years
Longitudinal description of patient reported outcomes at baseline, during and for up to 1 year following completion of radiotherapy.
Time Frame: 2.5 years
2.5 years
Predictive model built using baseline and longitudinal circulating-tumour DNA and radiomic features to predict benefit from consolidation immunotherapy.
Time Frame: 2.5 years
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.
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

Cancer Research UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Estimated)

September 24, 2024

Study Completion (Estimated)

September 24, 2025

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS001986
  • 299279 (Other Identifier: IRAS ID)
  • 22/NW/0297 (Other Identifier: REC number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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