LUCID - LUng Cancer CIrculating Tumour Dna Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ctDNA detection rate in all patients
研究概览
简要总结
This is a prospective observational pilot study to investigate levels of circulating tumour DNA (ctDNA) in plasma from patients with stage I to IIIB non-small cell lung cancer (NSCLC) who will undergo treatment with curative intent.
详细描述
Taking as reference tumour-specific somatic genetic alterations identified within individual cancer biopsies from patients, recent advances in genomic and next generation sequencing technologies now provide the opportunity to investigate whether each patient's tumour-specific DNA can be reliably detected within their plasma. This offers the possibility to test a patient's response following treatment with curative intent. This technology has already been used to detect ctDNA in metastatic NSCLC, but not yet in early stage disease.
The primary objective of this pilot study is to test the feasibility of detecting serial ctDNA levels in stage I to IIIB NSCLC patients who undergo treatment with curative intent. As secondary endpoints, this study aims to measure ctDNA levels and characteristics, and to correlate them with clinical features (such as burden of disease and treatment response) in order to test the value of ctDNA as a diagnostic, prognostic and predictive biomarker for patients with NSCLC.
100 patients planned for curative treatment (surgery or radical radiotherapy +/- chemotherapy) will be recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old at the time of consent
- •Male or Female
- •Patients with radiologically and histologically/cytologically confirmed stages I to IIIB NSCLC who are planning to undergo radical treatment (surgery or radical radiotherapy) with curative intent
- •ECOG Performance Status 0-2
- •Able to give informed consent
- •Able to give blood
排除标准
- •Unable to receive treatment with curative intent due to co-morbidity or personal choice
- •Patients participating in other clinical studies are not precluded from entering the study; however they must meet all the eligibility criteria for this study.
结局指标
主要结局
ctDNA detection rate in all patients
时间窗: Baseline blood sample
The primary endpoint is the ctDNA detection rate in the baseline blood sample of early stage NSCLC patients undergoing treatment with curative intent.
次要结局
- ctDNA baseline levels, genetic alterations and other features in all patients(Baseline blood sample)
- ctDNA levels, genetic alterations and other characteristics with clinical features in all patients(Blood samples will be taken at routine clinic visits through study completion, an average of 3 years.)
- Comparison of ctDNA levels and mutation profile at relapse to that obtained at earlier time points(Blood samples will be taken at relapse through study completion, an average of 3 years.)
- Correlate the genetic alterations found in different regions of each tumour with histological features and genetic alterations in the ctDNA(Lung tumour tissue will be collected from surgery through end of study, an average of 3 years.)
- Test ctDNA levels, genetic alterations or other characteristics during and after treatment with radical radiotherapy(Blood samples will be taken every week of radiotherapy and at follow-up clinic visits, approximately every 3 months for 9 months after the end of treatment)
- Establish a library of samples for future analysis(Blood samples will be taken at baseline, during treatment and at follow-up clinic visits, approximately every 3 months for 9 months after treatment)
研究者
CCTU- Cancer Theme
LUCID Trial Coordinator
Cambridge University Hospitals NHS Foundation Trust