March 11, 2020, Leah Lawrence – Researchers say they can distinguish between lesions that are benign and those that could become invasive — but the technology required is not yet used routinely. Testing only occurred among symptomatic patients. Circulating microDNA profiles may serve as a useful tool for lung cancer detection in symptomatic patients when used in conjunction with imaging, sputum cytology, and biopsy tests, according to the results of a multicenter, cohort study.
“Despite several publications on tumor biomarkers, few tissue-based biomarkers and virtually no new blood-borne biomarkers are used in clinical practice,” the researchers wrote. “The clinical application of biomarkers is largely hampered by the relatively small number of cases that have been analyzed in most preclinical studies. This limitation also applies to the studies of blood-borne miRNAs in patients with lung cancer.”
In this study, the researchers conducted genome-wide microRNA analyses from blood samples of 3046 individuals from case-control and cohort studies. Included samples were from people with non-small cell lung cancer or small cell lung cancer (606 individuals), non-tumor lung diseases (593 individuals), diseases not affecting the lung (883 individuals), and control participants (964 individuals).
The researchers looked at 3 classification scenarios by splitting the samples equally into training and validation sets.
First, they analyzed a 15-microRNA signature from the training set that attempted to distinguish those patients with lung cancer from other patients in the validation set. This signature had an accuracy of 91.4%, a sensitivity of 82.8%, and a specificity of 93.5%.
Next, the researchers tested a 14-microRNA signature designed to distinguish patients with lung cancer from those with non-tumor lung diseases. This signature had an accuracy of 92.5%, a sensitivity of 96.4%, and a specificity of 88.6%.
Finally, a 15-microRNA signature was tested to distinguish patients with early-stage lung cancer from all participants without lung cancer. The accuracy was 95.9%, sensitivity was 76.3%, and the specificity was 97.5%.
“Prospective studies with large cohorts of patients with specific diseases, a format that is readily applicable in clinical in vitro diagnostic tests (RT-qPCR or enzyme-linked immunosorbent assay [ELISA]), and an evaluation of the extent to which the miRNA signatures may complement imaging, sputum cytology, or biopsy are needed for clinical application of miRNA for diagnosis of lung cancer,” the researchers wrote.
Disclosures: The study was partially funded by Hummingbird Diagnostics (HBDx), the BestAgeing grant (EU FP7), the Michael J Fox Foundation, and the Deutsche Krebshilfe. Some of the authors disclosed financial relationships with pharmaceutical and/or medical device companies; for a full list of disclosures, please refer to the original study.
Fehlmann T, Kahraman M, Ludwig N, et al. Evaluating the use of circulating microDNA profiles for lung cancer detection in symptomatic patients [published online March 5, 2020]. JAMA Oncol. 2020;doi:10.1001/jamaoncol.2020.0001.