Training set samples were used to select the markers for the panel using Nucleix's proprietary bioinformatics techniques (Nucleix, Rehovot, Israel). Six markers were selected based on their synergistic information and an algorithm calculating the EpiScore was developed and locked down (supplementary figure S1). Two cut-offs were defined to allow for different clinical scenarios, a low cut-off (LCO) of EpiScore ≥60, favouring high sensitivity, and a high cut-off (HCO) of EpiScore ≥70, favouring high specificity. The European validation set was a new set of samples used to validate the performance of the assay using the pre-defined algorithm and cut-offs.

The training and the European validation sets were obtained by applying a single protocol: a case–control study performed on samples from sequential recruitment in 18 departments and clinics in 16 healthcare organisations, and three biobanks in Europe and Israel (supplementary table S2). Samples were collected from July 2016 to March 2018. The initial series of cases and controls were used for training and the subsequent series was used for validation. Cases were recruited from pulmonology, thoracic surgery and oncology departments and clinics in Europe and Israel. Present and past smokers, serving as controls, were recruited from blood collection stations in primary care clinics and from general surgery departments in Israel. Potential participants were randomly approached as they came to perform a blood test for any reason (table 1). Sample processing was performed at the Nucleix laboratory (Rehovot). Disease staging of the cases was according to the American Joint Committee on Cancer staging manual (AJCC)7 and AJCC8. Adenocarcinomas were included only if classified as invasive adenocarcinomas according to International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society classification [11].

Eligibility criteria

NSCLC: nonsmall cell lung cancer; SCLC: small cell lung cancer.

The Chinese validation set was a small feasibility study assessing the applicability of Lung EpiCheck for lung cancer detection in a Chinese population. This was a blinded, case–control, single-centre study performed in the Lung Cancer Center/Lung Cancer Institute at the West China Hospital (Sichuan University, Chengdu, China). Samples were collected from January 2018 to November 2018. Patients suspected or confirmed to have lung cancer arriving for lung surgery were enrolled. Healthy volunteers were enrolled sequentially as controls (table 1). Sample processing was performed on site. Disease staging for the cases was according to AJCC8.

Relevant medical, smoking and family history data were collected prior to study-related procedures. The study was approved by the ethics committees of the various institutions involved, and all subjects provided signed informed consent. The study registration number is NCT02373917.

Note: The content above has been extracted from a research article, so it may not display correctly.



Q&A
Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.



We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.