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A serum circulating miRNA diagnostic test to identify asymptomatic high-risk individuals with early stage lung cancer.

ABSTRACT: Lung cancer is the first cause of cancer mortality worldwide, and its early detection is currently the main available strategy to improve disease prognosis. While early diagnosis can be successfully achieved through tomography-based population screenings in high-risk individuals, simple methodologies are needed for effective cancer prevention programs. We developed a test, based on the detection of 34 microRNAs (miRNAs) from serum, that could identify patients with early stage non-small cell lung carcinomas (NSCLCs) in a population of asymptomatic high-risk individuals with 80% accuracy. The signature could assign disease probability accurately either in asymptomatic or symptomatic patients, is able to distinguish between benign and malignant lesions, and to capture the onset of the malignant disease in individual patients over time. Thus, our test displays a number of features of clinical relevance that project its utility in programs for the early detection of NSCLC.

SUBMITTER: Bianchi F

PROVIDER: S-EPMC3377091 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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A serum circulating miRNA diagnostic test to identify asymptomatic high-risk individuals with early stage lung cancer.

Bianchi Fabrizio F Nicassio Francesco F Marzi Matteo M Belloni Elena E Dall'olio Valentina V Bernard Loris L Pelosi Giuseppe G Maisonneuve Patrick P Veronesi Giulia G Di Fiore Pier Paolo PP

EMBO molecular medicine 20110711 8

Lung cancer is the first cause of cancer mortality worldwide, and its early detection is currently the main available strategy to improve disease prognosis. While early diagnosis can be successfully achieved through tomography-based population screenings in high-risk individuals, simple methodologies are needed for effective cancer prevention programs. We developed a test, based on the detection of 34 microRNAs (miRNAs) from serum, that could identify patients with early stage non-small cell lun ...[more]

PMID: 21744498

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Project description:BackgroundBladder cancer (BC) is the tenth most common cancer in the world. Serum microRNA (miRNA) profiles previously have been reported as non-invasive biomarkers in cancer screening. The non-invasive and reliable diagnostic biomarkers are urgently needed for detecting BC, while cystoscopy is invasive. Our study aimed to identify candidate miRNAs in serum as potential diagnostic biomarkers for BC detection.MethodsThis study was including the screening stage, training stage, and validation stage with 137 BC patients and 127 healthy controls (HCs). We identified the expression of 28 serum miRNAs from 5 BC pools and 3 HC pools in the initial screening stage. The other 112 BC patients and 112 HCs were randomly divided into training stage with 30 BC patients and 30 HCs and validation stages with 82 BC patients and 82 HCs. These HCs matched BC patients based on age and gender with P value >0.05. Identified dysregulated miRNAs were further confirmed in the training stage, and validation stages by quantitative reverse transcription-polymerase chain reaction (qRT-PCR). The diagnostic value of miRNAs was assessed by receiver operating characteristic (ROC) curves and the area under the ROC curve (AUC). Target genes of 3 candidate miRNAs were predicted by bioinformatic analysis.ResultsFive miRNAs (miR-106a-5p, miR-145-5p, miR-132-3p, miR-7-5p and miR-148b-3p) in serum were obviously dysregulated in BC patients compared to HCs. The ability to diagnose BC of 3 candidate miRNAs was estimated by AUC, with miR-132-3p (AUC =0.781; sensitivity =68.29%, specificity =81.71%), miR-7-5p (AUC =0.778; sensitivity =59.76%, specificity =84.15%) and miR-148b-3p (AUC =0.837; sensitivity =81.71%, specificity =71.95%). Combined application of these candidate miRNAs with parallel test could improve the diagnostic value (AUC =0.922; sensitivity =90.24%, specificity =81.71%). BNC2, GAS7, and NTRK2, considered as target genes of the three-miRNA panel, may play an important role in the process of BC development.ConclusionsA three-miRNA panel in serum was identified for BC diagnosis in our study, which HCs were used for differential diagnosis. The three-miRNA panel (miR-132-3p, miR-7-5p, and miR-148b-3p) might be performed as a non-invasive and convenient diagnostic tool for BC screening and diagnosis.

Project description:BackgroundThe International Classification of Diseases (ICD) coding system is the industry standard tool for billing, disease classification, and epidemiology purposes. However, ICD codes are often not assigned or incorrectly given, particularly among Chronic Kidney disease (CKD) patients. Our study evaluated the diagnostic accuracy of CKD-staging ICD codes among CKD patients from a large insurer database in identifying individuals rapidly progressing towards end-stage renal disease (ESRD).Patients and methodsSerial observations including outpatient serum creatinine measurements collected from 2007 through 2014 of 216,529 patients were examined. The progression of CKD using a serum creatinine based longitudinal mixed-model was contrasted with that documented by CKD-staging ICD codes. Rapid progressors, defined as those with yearly estimated glomerular filtration rate (eGFR) loss greater than 4 ml/min/1.73m2) were identified. The diagnosis of CKD using eGFR was also compared to diagnosis using a set of CKD related ICD codes.ResultsOf 10,927 clinically identified CKD patients qualifying for inclusion in the progression analysis, 323 were clinically identified as rapid progressors. CKD-staging ICD codes identified 83 of these, for a sensitivity of 25.7% with positive predictive value (PPV) of 13.74%, and specificity 95.09% with negative predictive value (NPV) of 97.68%. Of 28,762 laboratory-confirmed CKD patients, 9249 had a qualifying ICD code, for a sensitivity of 16% with PPV of 63.10%; Of 187,767 patients with laboratory-confirmed absence of CKD, 182,359 also did not have a qualifying ICD code, for a specificity of 97.12% with NPV of 90.33%.ConclusionThis study depicts the novel finding that ICD-codes display poor capacity to identify rapidly progressing CKD patients when compared to gold standard eGFR measures, and further demonstrates the limitations of coding in CKD diagnosis. This analysis further defines the limitations of ICD codes in addressing diagnosis of disease severity or disease progression for clinical or epidemiological purposes.

Dataset Information

A serum circulating miRNA diagnostic test to identify asymptomatic high-risk individuals with early stage lung cancer.

Publications

A serum circulating miRNA diagnostic test to identify asymptomatic high-risk individuals with early stage lung cancer.

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