King's College London started a new clinical trial of Lung Cancer detection using blood exosomes and HRCT
Photo by Darius Bashar
King's College London is commencing recruitment for the clinical trial of the Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging.
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.
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.
This 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.
Participants will have normal standard of care chest CT scans and this data will be used.
All participants will be actively followed for 3 months and then those with nodules, revealed by CT Scan, at 3 monthly intervals. Longitudinal clinical data will be collected on the investigations, diagnoses and outcomes of all study patients.
Data will be collected on date, type and results of imaging and biopsy investigations including nodule size and progression.
For those diagnosed with lung cancer, data on tumour size, stage, type and other markers) will be recorded together with treatment response and date of death, where this occurs within the study.
A new clinical trial is recruiting patients in the following locations: Borthwick Research Unit, Lister Hospital, Stevenage, United Kingdom, SG1 4AB.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04629079.
