Lung Cancer Detection Using Blood Exosomes and HRCT- Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population.
研究概览
简要总结
This project aims to validate exosomal assays that are based on hypoxia detection as potential biomarkers of early detection. The study analysis will determine whether the assay can detect clinical lung cancer at the time of imaging and interval cancers during subsequent follow up. The study aims to establish preliminary sensitivity/specificity data for the "combined CT/exosomal risk stratification marker" and provide initial data on the potential association of the "combined CT/exosomal risk score" with the subsequent cancer progression and treatment response.
详细描述
Lung cancer is the leading cause of cancer deaths. Screening for early detection of cancer at an early stage reduces cancer deaths and therefore improves prognosis. The National Lung Screening Trial (NLST), for instance, showed that CT screening increases the early detection rate, and reduces mortality. However, drawbacks include over-diagnosis, false-positive results, psychological distress and cost. Therefore, lung cancer screening is not recommended or available within the NHS.
Diagnosis of lung cancer is currently based on a combination of scans and tissue biopsy. The invasive nature of current diagnostic procedures limits their application. To improve the efficacy and cost effectiveness of screening in early detection of lung cancer, additional, complementary and non-invasive methods, such as circulating biomarkers, should be evaluated. Our novel exosomal assay (taken from a blood sample) when combined with CT, may improve the current accuracy of lung cancer detection, especially that of a worse clinical prognosis. Improvement in the accuracy of detection and/or prediction of future disease by performing the combined imaging exosome test will cause a paradigm shift. Moving towards the identification of blood tests can help increase confidence about follow-up decisions and shorten the interval before biopsy.
This prospective cohort study will recruit patients referred to secondary care for the investigation of clinical symptoms or signs suspicious of lung cancer.
The study will run between 2020 and 2024 (two-year active recruitment and two-year follow up).
Participants will have a single assay of blood taken on one occasion in the lung clinic by trained staff.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Suspected clinical diagnosis of lung cancer
- •Able to provide informed consent
排除标准
- •Synchronous other cancer types.
结局指标
主要结局
Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population.
时间窗: Through study completion, an average of 2 years.
Describe the expression of hypoxia- response element (HRE) responsible protein P4HA1 utilising a hypoxia-reporting cancer exosomal assay in participants being clinically assessed for suspected lung cancer.
次要结局
- Develop a combined risk score combining multi-dimensional parameters to discriminate between cancer cases and non-cancer cases.(Through study completion, an average of 2 years.)
- Describe the range of expression of precursor microRNA in exosomes derived from participants being clinically assessed for suspected lung cancer and compare the range of expression between the cancer and non-cancer participant population.(Through study completion, an average of 2 years.)