Everest Early Detection Assay for Detecting Lung Cancer
Research type
Research Study
Full title
Protocol for a Pilot Study to Evaluate the Performance of the Everest Early Detection Assay for Detecting Lung Cancer Cells in Human Blood Samples
IRAS ID
252943
Contact name
Neil Smith
Contact email
Sponsor organisation
Everest Detection
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
This pilot study is designed to evaluate the feasibility of the Everest Lung Cancer Early Detection Assay for detecting circulating tumor cells (CTCs) in the blood of patients with lung cancer. Samples collected during the Community Lung Health Study (CLHS) will be tested alongside samples from donors diagnosed with lung cancer, which will serve as positive sample controls, and samples from healthy donors (i.e., no known disease diagnosis, e.g., presence of cancer or any inflammatory diseases, etc.) with targeted age under 25 years old, who are non-smokers and have no other known risk factors for cancer. The performance of the Everest Early Detection Assay in this pilot study will be assessed using accuracy, sensitivity, and specificity when comparing to clinical outcomes provided by Community Lung Health Study investigators and negative percent agreement and positive percent agreement when comparing to a genomic reference method(s). If this pilot study supports that the Everest Lung Cancer Early Detection Assay can detect CTCs in the blood of participants with lung cancer, additional studies will be established to develop an assay further.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1711
Date of REC Opinion
25 Sep 2018
REC opinion
Favourable Opinion