Second Primary Lung Cancer Cohort Study (SPORT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer.
时间窗: 5 years
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
次要结局
- To collect blood samples from the cohort of patients.(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.(Identify original diagnostic sample at recruitment.)
- To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients(From recruitment to end of study (or 5 year follow up point, whichever comes first))