Abstract Rationale The Percepta Nasal Swab test (PNS) is a genomic classifier that uses whole transcriptome (RNA) data from nasal epithelial cells obtained by cytologic brushing combined with clinical factors to classify the risk of lung cancer in patients with a PN and a history of smoking 100 cigarettes. In a clinical validation study (Lamb CR et al. Chest. 2024 Apr;165(4):1009-1019.) the test demonstrated a sensitivity of 97% and specificity of 40% when categorizing a PN as low-risk for lung cancer and a sensitivity of 57% and a specificity of 92% when categorizing a PN as high-risk for lung cancer. The NOBLE Trial (Nose Brushings for Lung Cancer Assessment in Epithelium) is a multi-center, prospective biospecimen collection trial intended to show the performance of PNS for lung cancer risk assessment in an orthogonal validation cohort from both groups. The study also enrolled patients outside the inclusion criteria for the original CV study (notably never smokers and patients with other exposures) for exploratory analysis. We report baseline clinical and radiographic differences between those two groups. Methods Patients were recruited from 18 sites. Arm 1 included patients with a PN identified on screening LDCT. Patients were eligible if they met USPSTF criteria for screening and had a PN classified as Lung-RADS 3 or 4. In Arm 2, patients were eligible if ≥ 35 years of age with an incidental finding of a PN ≥ 6 mm independent of smoking status. Differences between groups were analyzed using Mann-Whitney U or chi-squared tests. Results 800 patients were enrolled. There were 520 (65%) in the incidental arm and 280 (35%) in the screening arm. The median age was 67 years (95% CI 61-73) in both arms. Screening patients were more likely male (54%) whereas incidental patients were more likely female (55%) (p = 0.033). 73% of incidental patients were current or former smokers compared to 100% in the screening arm; 21% of incidental patients were current smokers compared to 56% in the screening arm (p 0.001). Median pack years was lower in the incidental arm (21 vs 53 pack years, p 0.001). PN were larger in the incidental arm (13 vs. 10 mm, p 0.001) but were equally likely to be spiculated (18% in both arms). Conclusions There are marked clinical differences between patients with screening-identified PN and those with incidental PN. PNS performance will be reported after clinical follow up with 5 years of radiographic surveillance. This abstract is funded by: Veracyte, Inc.
Bansal et al. (Fri,) studied this question.