Second Primary Lung Cancer Cohort Study (SPORT)

Study Overview
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Brief Summary
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Patients who have had curative treatment for lung cancer are at an increased risk of developing second primary lung cancers (and other cancers) over the next 10 years. Doctors need to develop better ways of monitoring patients during follow up so we can intervene as quickly as possible with further treatments. Measuring DNA in the blood which has come from the tumour, so called circulating tumour DNA (ctDNA), may be one way to do this.

Detailed Description
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This is a multi-centre, observational basic science study to follow patient who have undergone radical treatment, surgery or radiotherapy for Non-small Cell Lung Cancer (NSCLC) between two and five years previously. Following consent, participants will be asked to provide blood samples every six months for up to the next five years. Information from their routine clinical care, including information from any imaging, diagnostic tissue samples and blood tests will be collected. We will also request access to any original surplus diagnostic material, as well as future, excess tissue from diagnostic samples. Blood samples will be analysed using various new scientific techniques looking to correlate emergence of new primary cancer (or recurrence of original NSCLC) with blood based markers.

Official Title
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Second Primary Lung Cancer Cohort Study (SPORT)

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previous treatment with curative intent (surgery or radical (chemo)radiotherapy) for stage I-IIIA primary NSCLC at least two years post first treatment date of first primary NSCLC able to provide informed consent Exclusion Criteria: Primary lung tumour was a carcinoid tumour in the opinion of the managing clinician, thought unlikely to survive 12 months from time of potential recruitment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer. | In order to: collect baseline demographics, clinical and past medical history to obtain blood samples every 6 months after recruitment to collect relevant imaging and clinical data as part of their on-going routine clinical care | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect blood samples from the cohort of patients. | Have the blood samples been collected at follow up visits. | From recruitment through to end of study (or 5 year follow up point, whichever comes first) | 
| To collect surplus diagnostic tissue from the cohort of patients. | To collect surplus diagnostic tissue from original non-small cell lung cancer. | Identify original diagnostic sample at recruitment. | 
| To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients | Collection of surplus diagnostic tissue if any second primary cancer or recurrence occurs. | From recruitment to end of study (or 5 year follow up point, whichever comes first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Non-small cell lung cancer