None listed
Conditions
Brief summary
This is an observational study which aims to see if levels of circulating tumour cells (CTCs) mobilised during curative-intent radiotherapy (RT) for non-small cell lung cancer (NSCLC) can be used to predict disease progression and development of metastases. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been deemed eligible to receive RT for NSCLC after positron emission tomography (PET) staging. Study details All participants will have collection of blood samples to measure the level of CTCs, pre-treatment, up to 3 pre-defined intervals (24 hours after commencement of radiotherapy, midway through radiotherapy, and final week of radiotherapy) throughout treatment and at disease assessment. A further sample will be taken at the time of suspected relapse, should this occur. These samples are collected on days participants are already attending the hospital. This will then be analysed to determine the correlation with survival, metastasis, local disease progression, and thromboembolic events (i.e. the development of blood clots) as determined by a review of medical records. The DNA of CTC samples will also be assessed to determine whether this influences any of the above parameters. Participants will be followed up in clinic as per standard of care requirements at 3 monthly intervals from completion of radiotherapy (or more often if required clinically) until last patient enrolled completes one year follow up. It is hoped that this study may show whether changes in CTC or CTC DNA levels after radiotherapy may have prognostic significance. Although this will not influence your current treatment, this may be used to inform the treatment of patients with NSCLC in future.
Interventions
Standard Radiation Therapy with Curative intent, Blood collection for biomarker analysis. Blood samples will be collected prior to radiotherapy treatment, up to 3 pre-defined intervals during treatment (24 hours after commencement of radiotherapy, mid point of radiotherapy and final week of radiotherapy) and a sample at 6-8 weeks post radiotherapy treatment which will coincide with response assessment imaging. A further sample will be taken at the time of suspected relapse, should this occur. Blood samples will be collected on days you are already visiting the hospital. Follow up for overall survival, freedom from metastasis, freedom from disease progression, and thromboembolic events will continue until the last trial participant completes 1 years follow-up. This is routine care and the information will be collected from your medical record with no further involvement required.
Sponsors
Eligibility
Inclusion criteria
Patients eligible for curative Radiation Therapy for Non-Small Cell Lung Cancer after PET staging
Exclusion criteria
Low Tumour burden (Largest Tumour <2cm in diameter). Women who are pregnant or lactating.