Prospective and single-blinded evaluation of the multi-cancer Carcimun-test

Abstract

Background: Timely diagnosis of cancer enables early treatment when interventions are most effective, but most cancer patients are being diagnosed at late stages after considerable tumor progression. Since current in vitro diagnostic tools identify distinct tumor derived proteins or mutations specific for certain types of tumors only, a more universal marker would foster early diagnosis. The Carcimun-test presented here detects specific conformational changes of plasma proteins in response to cancerogenesis by the optical extinction measurement thereby indicating general malignancy and acute inflammation. In this study, we assessed the feasibility and performance of the Carcimun-test in healthy volunteers and cancer patients. Methods: In this prospective, single-blinded study, plasma samples were obtained from 137 healthy donors and 170 patients with different histologically proven malignancies and subsequently assayed by Carcimuntesting. Participants with acute and chronic inflammation were excluded. An extinction threshold was defined to differentiate between healthy individuals and cancer patients. Participants were then followed-up to up to 5 years after Carcimun-testing to correlate test results with mortality and define false negative rate. Results: In the Carcimun-test, mean extinction values were significantly higher in cancer patients (n=170) than in healthy subjects (n=137; P<0.000) and tended to increase from tumor stage I to IV. Applying an extinction cut-off value [120], 89.6% of study participants (275/307) were either correctly identified as healthy individuals (124/137) or patients with different cancers (151/170), resulting in high levels of accuracy (90.0%), sensitivity (88.8%), and specificity (91.2%). The positive and negative predictive values were 92.0% and 87.0%, respectively. At the follow-up 29.1±1.24 [standard of the mean (SEM)] months of true negative (n=124/137) and true positive participants (n=151/170), all-cause mortality was below 10% in healthy individuals and over 50% in cancer patients (P<0.002). Conclusions: With the Carcimun-test, we present a clinically feasible tool to detect different tumor types with high specificity, sensitivity, and accuracy. Further studies are now planned to delineate the molecular mechanism of the Carcimun-test and to demonstrate its clinical relevance for the screening and early diagnosis of cancer.