Abstract
BackgroundsWe previously reported a highly sensitive method for serum human telomerase reverse transcriptase (hTERT) mRNA for hepatocellular carcinoma (HCC). α-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) are good markers for HCC. In this study, we verified the significance of hTERTmRNA in a large scale multi-centered trial, collating quantified values with clinical course.MethodsIn 638 subjects including 303 patients with HCC, 89 with chronic hepatitis (CH), 45 with liver cirrhosis (LC) and 201 healthy individuals, we quantified serum hTERTmRNA using the real-time RT-PCR. We examined its sensitivity and specificity in HCC diagnosis, clinical significance, ROC curve analysis in comparison with other tumor markers, and its correlations with the clinical parameters using Pearson relative test and multivariate analyses. Furthermore, we performed a prospective and comparative study to observe the change of biomarkers, including hTERTmRNA in HCC patients receiving anti-cancer therapies.ResultshTERTmRNA was demonstrated to be independently correlated with clinical parameters; tumor size and tumor differentiation (P < 0.001, each). The sensitivity/specificity of hTERTmRNA in HCC diagnosis showed 90.2%/85.4% for hTERT. hTERTmRNA proved to be superior to AFP, AFP-L3, and DCP in the diagnosis and underwent an indisputable change in response to therapy. The detection rate of small HCC by hTERTmRNA was superior to the other markers.ConclusionshTERTmRNA is superior to conventional tumor markers in the diagnosis and recurrence of HCC at an early stage.
Highlights
Since the discovery of circulating nucleic acids (CNAs) in plasma in 1948, many diagnostic applications have emerged
Since hepatocellular carcinoma (HCC) has been recently classified as a complex disease with a wide range of risk factors and many cellular signaling pathways have been reported to be involved in hepatocarcinogenesis, a novel biomarker for HCC is required [21]
We previously reported that measurement of serum hTERTmRNA by real-time reverse transcription-PCR (RT-PCR) method was sensitive in detection of tumor-derived hTERTmRNA even in the HCC patients whose AFP levels were low [9], and was useful even for other malignancies such as non-small cell lung cancer, ovarian cancer, and gastric cancer [22,23,24]
Summary
Since the discovery of circulating nucleic acids (CNAs) in plasma in 1948, many diagnostic applications have emerged. In addition to DNA-derived from tumor cells [1,2,3,4], a recent development in this new field is the finding of tumor-related RNA in the plasma/serum of cancer patients [5]. These features include tyrosine kinase mRNA [6], telomerase components [7,8], the mRNAs that are encoded by different tumor-related genes [9,10,11,12,13], and viral mRNA [14]. Dasi et al showed that circulating telomerase RNA is a sensitive marker, using real-time reverse transcription-PCR (RT-PCR) [8]
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