Lung Health Check Biomarker Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Feasibility of the primary objective to collate a lung health check biobank
研究概览
简要总结
CT screening of lung cancer offers an opportunity to diagnose early stage lung cancers which is associated with better prognosis - indeterminate results delay diagnosis whilst interval imaging is awaited to assess risk of cancer. This study will allow us to examine the potential of blood-based biomarkers to augment CT screening for lung cancer.
Hypotheses
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Blood and sputum samples can be collected in patients attending lung health checks as part of the Lung Health Check pilot in West London at fixed and mobile scanners and safely transported for processing and storage in preparation for biomarker development.
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The biomarkers will help to identify cohorts of
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High-risk patients in whom CT surveillance should be conducted more readily/frequently and diagnostic procedures performed earlier.
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Low-risk patients who might need reduced surveillance intensity.
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Patients with interstitial lung abnormalities that share similar biomarker characteristics to patients with clinically significant interstitial lung disease
详细描述
- Background 1.1 Lung cancer & CT screening Over 46,000 cases of lung cancer are diagnosed every year in the UK, making it the 3rd most common cancer type. Lung cancer is the biggest cause of cancer mortality in the UK and worldwide due to late presentation in the majority of cases. One year survival for lung cancer ranges from 83% at stage I to 17% in stage IV disease (CRUK data).
Reduced lung cancer mortality (20-26%) can be achieved by Lung Health Checks - which use 'low dose' CT (LDCT) scans of high-risk populations (e.g. heavy smokers), by increasing the proportion of cases diagnosed at an earlier stage when the treatment options are better (National Lung Cancer Screening Trial and NELSON studies). A number of pilot trials within the UK have led to a commitment by NHS England to roll-out a £70m national pilot. RM Partners commenced recruitment to one of the earlier pilots across two clinical commissioning groups (CCGs) in West London in 2018, inviting approximately 1000 patients for an LDCT scan at a fixed and mobile scanner (based in a supermarket car park). This pilot will be extended in 2019-2020 with a further 1000-2000 patients - this will include both new patients and others who will have a 24 month 'incident scan' to re-examine for any new cancer after a previously normal baseline scan). This study will test the uptake and feasibility of biomarker testing and potential scientific opportunities from specimens received.
1.2 Current Limitations of Lung Health Checks A) Patient Selection: Two lung cancer risk calculators, the modified Liverpool Lung Project (LLPv2) and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) are both multivariate risk prediction models which have been used to select patients for screening. Both models have been used to support the identification of high risk individuals during the Lung Health Check pilot to determine the risk of lung cancer and stratifying for LDCT screens. Improved patient selection has been identified as a priority to improve the sensitivity and specificity of lung health checks.
B) Indeterminate Findings: In addition management of indeterminate 'nodules' which can be either small, possibly early cancers, or benign scarring requires delayed e.g. 3 or 12 month surveillance scans to stratify more invasive procedures such as lung biopsy to confirm the diagnosis. Blood biomarkers capable of identifying patients at increased risk of developing or harbouring lung cancer would be valuable adjuncts to protocols for surveillance and invasive monitoring. Nodules are seen in approximately 10% of scans.
Existing clinical scores (e.g. Brock score) could be improved upon (see British Thoracic Society guidelines) and there remains significant clinical uncertainty about best management in patients with indeterminate nodules.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients invited to participate in the Royal Marsden (RM) Partners Lung Health Check pilot study who undergo one or more CT scans:
- •Between the age of 55-75 years of age; and
- •Current smokers or ex-smokers who have quit after the age of 40.
排除标准
- •Patients excluded from the Lung Health Check:
- •On the palliative care register;
- •Any active malignancy undergoing treatment
- •Daily activity levels equivalent to performance score 3 or 4; and
- •Unable to consent to Lung Health Check Biomarker Study
结局指标
主要结局
Feasibility of the primary objective to collate a lung health check biobank
时间窗: 2 Years
The feasibility of the primary objective to collate a lung health check biobank will be reported as a percentage after the final participant recruited has donated both a baseline sample and also their final specimen (or on the same date should they decline to do so). The primary end point of the project will be considered feasible if consent to a blood test, collection and storage can be achieved in at least 50% of the 1000 patients approached for the biomarker study who undertake an LDCT scan.
次要结局
- Confirming if peripheral blood telomere length can determine those who have interstitial lung abnormalities at those who do not, and who is at higher risk of developing overt pulmonary fibrosis(2 years)
- Confirming if a lung cancer genomics panel differs between participants who receive a diagnosis of lung cancer at the time of the baseline scan and those who do not(2 Years)
- Confirming if a lung cancer genomics panel (taken at baseline LDCT screening scans) differs between those who receive a diagnosis of lung cancer and those who do not after completion of follow-up imaging(2 years)