Shlomi Dekel, Peled Nir, Schwarz Yehuda A, Soo Hoo Guy W, Batra Raj K, Fink Gershon, Kaplan Tal, Cohen Lahav, Mollan Scott, Burfeind William R
Pulmonary Clinic, Dan Petah-Tiqwa District, Clalit Health Services, Israel.
The Cancer Institute, Soroka Medical Center & Ben-Gurion University, Beer-Sheva, Israel.
Cancer Genet. 2018 Oct;226-227:1-10. doi: 10.1016/j.cancergen.2018.04.118. Epub 2018 May 10.
Early detection decreases lung cancer mortality. The Target-FISH Lung Cancer Detection (LCD) Test is a non-invasive test designed to detect chromosomal changes (deletion or amplification) via Fluorescence in situ Hybridization (FISH) in sputum specimens from persons suspected of having lung cancer. We evaluated the performance of the LCD test in patients with highly suspicious pulmonary nodules who were scheduled for a biopsy procedure.
Induced sputum was collected from patients who were scheduled for biopsy of a solitary pulmonary nodule (0.8-3 cm) in one of 6 tertiary medical centers in the US and Israel. The lung cancer detection (LCD) Test combined sputum cytology and Target-FISH analysis on the same target cells and the results were compared to the pathology. Participants with non-surgical negative biopsy results were followed for 2 years to determine their final diagnosis.
Of the 173 participants who were evaluated, 112 were available for analysis. Overall, the LCD test had a sensitivity of 85.5% (95% CI, 76.1-92.3), specificity of 69% (95% CI, 49.2-84.7) and an accuracy of 81.3% (95% CI, 72.8-88). The positive and negative predictive values (PPV, NPV) were 88.8% and 62.5%, respectively. The LCD test was positive in 9 of 11 lung cancer patients who had an initial negative biopsy.
In a cohort of patients with highly suspicious lung nodules, the LCD test is a non-invasive option with good sensitivity and a high positive predictive value. A positive LCD test reinforces the need to aggressively pursue a definitive diagnosis of suspicious nodules.
早期检测可降低肺癌死亡率。靶向荧光原位杂交肺癌检测（LCD）试验是一种非侵入性检测方法，旨在通过荧光原位杂交（FISH）检测疑似肺癌患者痰液标本中的染色体变化（缺失或扩增）。我们评估了LCD试验在计划进行活检的高度可疑肺结节患者中的性能。
在美国和以色列的6个三级医疗中心之一，从计划对孤立性肺结节（0.8 - 3厘米）进行活检的患者中收集诱导痰液。肺癌检测（LCD）试验将痰液细胞学和对相同靶细胞的靶向FISH分析相结合，并将结果与病理结果进行比较。对非手术活检结果为阴性的参与者进行了2年的随访，以确定其最终诊断。
在173名接受评估的参与者中，有112名可供分析。总体而言，LCD试验的敏感性为85.5%（95%置信区间，76.1 - 92.3），特异性为69%（95%置信区间，49.2 - 84.7），准确性为81.3%（95%置信区间，72.8 - 88）。阳性和阴性预测值（PPV，NPV）分别为88.8%和62.5%。在11名最初活检为阴性的肺癌患者中，有9名LCD试验呈阳性。
在一组高度可疑肺结节患者中，LCD试验是一种具有良好敏感性和高阳性预测值的非侵入性选择。LCD试验阳性强化了对可疑结节进行积极明确诊断的必要性。
