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Trial Title:
Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer
NCT ID:
NCT06086574
Condition:
Lung Cancer Stage III
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Non small cell lung cancer
NSCLC
Stage III
Radiotherapy
Biomarker
Circulating-tumour DNA
Radiomics
PROM
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients treated under The Christie NHS Foundation Trust, Greater Manchester
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ashley Horne
Phone:
0161 446 3000
Email:
the-christie.vigilance.lungtrial@nhs.net
Contact backup:
Last name:
Clare Dempsey
Email:
vigilance@manchester.ac.uk
Investigator:
Last name:
Corinne Faivre-Finn
Email:
Principal Investigator
Investigator:
Last name:
Ashley Horne
Email:
Sub-Investigator
Start date:
March 24, 2023
Completion date:
September 24, 2025
Lead sponsor:
Agency:
University of Manchester
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Source:
University of Manchester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086574
