scholarly journals A Cost-Effective and Non-Invasive pfeRNA-Based Test Differentiates Benign and Suspicious Pulmonary Nodules from Malignant Ones

2021 ◽  
Vol 7 (4) ◽  
pp. 80
Author(s):  
Wei Liu ◽  
Yuyan Wang ◽  
Hongchan Huang ◽  
Nadege Fackche ◽  
Kristen Rodgers ◽  
...  

The ability to differentiate between benign, suspicious, and malignant pulmonary nodules is imperative for definitive intervention in patients with early stage lung cancers. Here, we report that plasma protein functional effector sncRNAs (pfeRNAs) serve as non-invasive biomarkers for determining both the existence and the nature of pulmonary nodules in a three-stage study that included the healthy group, patients with benign pulmonary nodules, patients with suspicious nodules, and patients with malignant nodules. Following the standards required for a clinical laboratory improvement amendments (CLIA)-compliant laboratory-developed test (LDT), we identified a pfeRNA classifier containing 8 pfeRNAs in 108 biospecimens from 60 patients by sncRNA deep sequencing, deduced prediction rules using a separate training cohort of 198 plasma specimens, and then applied the prediction rules to another 230 plasma specimens in an independent validation cohort. The pfeRNA classifier could (1) differentiate patients with or without pulmonary nodules with an average sensitivity and specificity of 96.2% and 97.35% and (2) differentiate malignant versus benign pulmonary nodules with an average sensitivity and specificity of 77.1% and 74.25%. Our biomarkers are cost-effective, non-invasive, sensitive, and specific, and the qPCR-based method provides the possibility for automatic testing of robotic applications.

Author(s):  
Muhammad Nadeem Ashraf ◽  
Muhammad Hussain ◽  
Zulfiqar Habib

Diabetic Retinopathy (DR) is a major cause of blindness in diabetic patients. The increasing population of diabetic patients and difficulty to diagnose it at an early stage are limiting the screening capabilities of manual diagnosis by ophthalmologists. Color fundus images are widely used to detect DR lesions due to their comfortable, cost-effective and non-invasive acquisition procedure. Computer Aided Diagnosis (CAD) of DR based on these images can assist ophthalmologists and help in saving many sight years of diabetic patients. In a CAD system, preprocessing is a crucial phase, which significantly affects its performance. Commonly used preprocessing operations are the enhancement of poor contrast, balancing the illumination imbalance due to the spherical shape of a retina, noise reduction, image resizing to support multi-resolution, color normalization, extraction of a field of view (FOV), etc. Also, the presence of blood vessels and optic discs makes the lesion detection more challenging because these two artifacts exhibit specific attributes, which are similar to those of DR lesions. Preprocessing operations can be broadly divided into three categories: 1) fixing the native defects, 2) segmentation of blood vessels, and 3) localization and segmentation of optic discs. This paper presents a review of the state-of-the-art preprocessing techniques related to three categories of operations, highlighting their significant aspects and limitations. The survey is concluded with the most effective preprocessing methods, which have been shown to improve the accuracy and efficiency of the CAD systems.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4065-4065 ◽  
Author(s):  
Lihan Zhou ◽  
Jimmy So ◽  
Ritika Kapoor ◽  
Feng Zhu ◽  
Ruiyang Zou ◽  
...  

4065 Background: High mortality from gastric cancer is related to the late manifestation of its symptoms. A blood-based non-invasive biomarker with the ability to detect all stages of gastric cancer could significantly improve patient outcomes. We aimed to develop a novel serum miRNA assay for diagnosis of gastric cancer. Methods: We conducted a multi-center study involving 892 gastric cancer and control subjects from Singapore and Korea to develop a multi-target miRNA assay. Using RT-qPCR, we quantified the expressions of 578 serum miRNAs and constructed a 12-miR biomarker panel through multi-variant data analysis. The results were generated with the use of a logistic-regression algorithm, with the value of 40 or more considered to be positive. We subsequently validated this multi-miR assay in a large prospective cohort involving 4566 subjects and compared its performance with traditional markers such as H.Pylori and Pepsinogen. All participants underwent gastroscopy independent of the assay results. Results: Of the 4566 subjects that underwent gastroscopy and histopathological examination in the prospective cohort, 125 were diagnosed with gastric cancer. The 12-miR assay achieved an Area-Under-Curve (AUC) of 0.84, significantly outperforming (p-value < 0.01) that of H.Pylori (AUC of 0.64) and Pepsinogen (AUC of 0.62). The sensitivity of the miRNA assay in detecting early (stage 0-2) and late (stage 3-4) stage gastric cancer was 82.6% (95% CI, 68.6% to 92.2%) and 88.4% (95% CI, 78.4% to 94.9%) respectively at a specificity of 70.0% (95% CI, 67.8% to 71.9%). In comparison, H.Pylori showed a sensitivity of 80.4% at a specificity of 44.3% whereas the Pepsinogen showed sensitivity of 9.52% at a specificity of 95.3%. Using the miRNA assay as a pre-screening tool could potentially reduce number of endoscopy needed by 62% in detecting one case of gastric cancer. Conclusions: Our serum miRNA panel is a useful, non-invasive screening test for gastric cancer. It is cost-effective as it can reduce unnecessary diagnostic endoscopy.


2019 ◽  
Vol 35 (S1) ◽  
pp. 17-17
Author(s):  
Andrew Sutton ◽  
John Lamont ◽  
R. Evans ◽  
Kate Williamson ◽  
Declan O'Rourke ◽  
...  

IntroductionThe Institute of Health Economics offers a suite of analyses that provide developers an understanding of the expected commercial viability of an early stage health technology. In combination, these analyses form the Value-Engineered Translation framework. These methods incorporate innovative methods to manage uncertainty in early economic evaluations, in particular, moving beyond current stochastic assessments of headroom to account for inter-market variability in value hurdles, as well as incorporating social value premia considerations. An illustration of these methods is demonstrated using the example of a non-invasive diagnostic test (called DCRSHP) at an early stage of development, compared to current practice of cystoscopy in the diagnosis of bladder cancer.MethodsCompeting technologies were identified to inform the headroom assessment based on price and effectiveness. Then, a model-based cost-effectiveness analysis was undertaken incorporating headroom analysis, stochastic one-way sensitivity analysis, and value of information analysis using data from secondary sources.ResultsCurrently there are a number of non-invasive tests available, but none have sufficient test accuracy to be suitable for bladder cancer diagnosis alone. From the headroom analysis, DCRSHP can be priced at up to CAD 790 (i.e. USD 588) and still be cost-effective compared to the current practice of cystoscopy. Interestingly this price can be increased for patient groups that have lower levels of bladder cancer prevalence.ConclusionsThe requirements of economic evaluations depend on the stage of technology development, and analysis approaches must reflect this. The results here indicate that DCRSHP clears the value hurdle in terms of being cost-effective, and thus provides the opportunity to make a commercial return on future investment. Future analysis of DCRSHP could consider the cost drivers for development of the technology, including the regulatory pathways, costs associated with the intellectual asset management for the technology, and alternative manufacturing costs. All of which contribute to the research-to-practice continuum.


2021 ◽  
Vol 6 (5) ◽  
pp. 25-37
Author(s):  
Mahnoor Pracha ◽  
Amtullah Fatima ◽  
Najeebullah Alakozai ◽  
Azizullah Alakozai ◽  
Taiba Aslam ◽  
...  

Background: Ultrasound is a non-invasive imaging modality, and it is cost effective while CT in invasive that uses ionizing radiations, yet it is difficult on ultrasound to diagnose calculi in ureter hence for evaluation of ureteric calculi CT scan is gold standard modality. Objective: To compare the detection of renal& urinary tract calculi (nephrolithiasis & urolithiasis) on ultrasound and CT. Material and methods: The data bases PubMed, ProQuest, and Google scholar and research gate were searched with the key words: nephrolithiasis on ultrasound and CT, sensitivity, specificity, from 2010 to 2021. For inclusion and exclusion of studies independently screened the titles and abstracts of full and related articles. Articles that had information about nephrolithiasis, urolithiasis at ultrasound and CT and its sensitivity and specificity were included. Results:  In total, 28 studies were found on renal & urinary tract calculi at ultrasound and computed tomography. This literature review demonstrates that computed tomography is characterized by high sensitivity and specificity in diagnosing renal, ureteric calculi while ultrasound has low sensitivity and specificity. Conclusions: Ultrasound is the best modality for imaging calculi within the kidney, a well hyper echoic mass with posterior acoustic shadow is identified as stone on gray scale, color Doppler can be used for demarcation of stone. At Color Doppler twinkling artifact appears around the calculi hence it can be differentiated by hyper echoic renal sinuses but this is crucially dependant on the size and anatomical position of the stone. The ultrasonic evaluation either overestimates or misinterprets the calculi size while CT gives an exact measurement, position with authentic sensitivity and specificity. Hence, CT is the gold standard for detection of renal calculi. Recommendation: Ultrasound is a non-invasive imaging modality and it is cost effective while CT in invasive that uses ionizing radiations, yet it is difficult on ultrasound to diagnose calculi in ureter hence for evaluation of ureteric calculi CT scan is gold standard modality.


2021 ◽  
Vol 10 (21) ◽  
pp. 4984
Author(s):  
PierFrancesco Bassi ◽  
Luca Di Gianfrancesco ◽  
Luigi Salmaso ◽  
Mauro Ragonese ◽  
Giuseppe Palermo ◽  
...  

Background: Bladder cancer (BCa) emits specific volatile organic compounds (VOCs) in the urine headspace that can be detected by an electronic nose. The diagnostic performance of an electronic nose in detecting BCa was investigated in a pilot study. Methods: A prospective, single-center, controlled, non-randomized, phase 2 study was carried out on 198 consecutive subjects (102 with proven BCa, 96 controls). Urine samples were evaluated with an electronic nose provided with 32 volatile gas analyzer sensors. The tests were repeated at least two times per sample. Accuracy, sensitivity, specificity, and variability were evaluated using mainly the non-parametric combination method, permutation tests, and discriminant analysis classification. Results: Statistically significant differences between BCa patients and controls were reported by 28 (87.5%) of the 32 sensors. The overall discriminatory power, sensitivity, and specificity were 78.8%, 74.1%, and 76%, respectively; 13/96 (13.5%) controls and 29/102 (28.4%) BCa patients were misclassified as false positive and false negative, respectively. Where the most efficient sensors were selected, the sensitivity and specificity increased up to 91.1% (72.5–100) and 89.1% (81–95.8), respectively. None of the tumor characteristics represented independent predictors of device responsiveness. Conclusions: The electronic nose might represent a potentially reliable, quick, accurate, and cost-effective tool for non-invasive BCa diagnosis.


2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Zhougui Ling ◽  
Jifei Chen ◽  
Zhongwei Wen ◽  
Xiaomou Wei ◽  
Rui Su ◽  
...  

Background. Identifying malignant pulmonary nodules and detecting early-stage lung cancer (LC) could reduce mortality. This study investigated the clinical value of a seven-autoantibody (7-AAB) panel in combination with the Mayo model for the early detection of LC and distinguishing benign from malignant pulmonary nodules (MPNs). Methods. The concentrations of the elements of a 7-AAB panel were quantitated by enzyme-linked immunosorbent assay (ELISA) in 806 participants. The probability of MPNs was calculated using the Mayo predictive model. The performances of the 7-AAB panel and the Mayo model were analyzed by receiver operating characteristic (ROC) analyses, and the difference between groups was evaluated by chi-square tests ( χ 2 ). Results. The combined area under the ROC curve (AUC) for all 7 AABs was higher than that of a single one. The sensitivities of the 7-AAB panel were 67.5% in the stage I-II LC patients and 60.3% in the stage III-IV patients, with a specificity of 89.6% for the healthy controls and 83.1% for benign lung disease patients. The detection rate of the 7-AAB panel in the early-stage LC patients was higher than that of traditional tumor markers. The AUC of the 7-AAB panel in combination with the Mayo model was higher than that of the 7-AAB panel alone or the Mayo model alone in distinguishing MPN from benign nodules. For early-stage MPN, the sensitivity and specificity of the combination were 93.5% and 58.0%, respectively. For advanced-stage MPN, the sensitivity and specificity of the combination were 91.4% and 72.8%, respectively. The combination of the 7-AAB panel with the Mayo model significantly improved the detection rate of MPN, but the positive predictive value (PPV) and the specificity were not improved when compared with either the 7-AAB panel alone or the Mayo model alone. Conclusion. Our study confirmed the clinical value of the 7-AAB panel for the early detection of lung cancer and in combination with the Mayo model could be used to distinguish benign from malignant pulmonary nodules.


2019 ◽  
Vol 2 (2) ◽  
pp. 10-19
Author(s):  
Alper Baran Sözmen ◽  
Ahu Arslan Yildiz

Nanotechnological approaches are the latest modality for early stage detection of cancer. The need of rapid, non-invasive, patient specific, and informative techniques in cancer diagnostics lead to the utilization of nanotechnology, microfluidics, and lab-on-a-chip platforms for liquid biopsy, and the developments through these technologies increased the knowledge also for case specific applications. In this review, nanotechnology-based methodologies that are developed in the last decade for cancer diagnostics are investigated and are discussed under four main categories for the purpose of simplification as; nanochip based, nanofilm based, magnetic nanomaterial-based methods, and combinational utilization of multiple methodologies. We suggest a combinational approach on device development with an aim of producing a compact, cost effective, rapid, sensitive, and non-invasive diagnostic device as a conclusion of literature review.


2020 ◽  
Author(s):  
Zhougui Ling ◽  
Jifei Chen ◽  
Zhongwei Wen ◽  
Xiaomou Wei ◽  
Rui Su ◽  
...  

Abstract BACKGROUND: Identifying malignant pulmonary nodules and detecting early-stage lung cancer (LC) could reduce mortality. This study investigated the clinical value of a seven-autoantibody (7-AAB) panel in combination with the Mayo model for the early detection of LC and distinguishing benign from malignant pulmonary nodules (MPNs).METHODS: The concentrations of the elements of a 7-AAB panel were quantitated by enzyme-linked immunosorbent assay (ELISA) in 806 participants. The probability of MPNs was calculated using the Mayo predictive model. The 7-AAB panel and the Mayo model performances were analyzed by receiver operating characteristic (ROC) analyses, and the difference between groups was evaluated by Chi-square tests (χ2).RESULTS: The combined area under the ROC curve (AUC) for all 7 AABs was higher than that of a single one. The 7-AAB panel sensitivities were 67.5% in the stage I-II LC patients and 60.3% in stage III-IV patients, with a specificity of 89.6% for the healthy controls and 83.1% for benign lung disease patients. The detection rate of the 7-AAB panel in the early-stage LC patients was higher than that of traditional tumor markers. The AUC of the 7-AAB panel combined with the Mayo model was higher than that of the 7-AAB panel alone or the Mayo model alone in distinguishing MPN from benign nodules. For early-stage MPN, the sensitivity and specificity of the combination were 93.5% and 58.0%, respectively. For advanced-stage MPN, the sensitivity and specificity of the combination were 91.4% and 72.8%, respectively. The combination of the 7-AAB panel with the Mayo model significantly improved the detection rate of MPN, but the positive predictive value (PPV) and the specificity were not improved when compared with either the 7-AAB panel alone or the Mayo model alone.CONCLUSION: Our study confirmed the clinical value of the 7-AAB panel for the early detection of lung cancer, and in combination with the Mayo model, could be used to distinguish benign from malignant pulmonary nodules.


Diagnostics ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 2304
Author(s):  
Micah Z. Levine ◽  
Sam Goodman ◽  
Robert J. Lentz ◽  
Fabien Maldonado ◽  
Otis B. Rickman ◽  
...  

The field of interventional pulmonology (IP) has grown from a fringe subspecialty utilized in only a few centers worldwide to a standard component in advanced medical centers. IP is increasingly recognized for its value in patient care and its ability to deliver minimally invasive and cost-effective diagnostics and treatments. This article will provide an in-depth review of advanced bronchoscopic technologies used by IP physicians focusing on pulmonary nodules. While most pulmonary nodules are benign, malignant nodules represent the earliest detectable manifestation of lung cancer. Lung cancer is the second most common and the deadliest cancer worldwide. Differentiating benign from malignant nodules is clinically challenging as these entities are often indistinguishable radiographically. Tissue biopsy is often required to discriminate benign from malignant nodule etiologies. A safe and accurate means of definitively differentiating benign from malignant nodules would be highly valuable for patients, and the medical system at large. This would translate into a greater number of early-stage cancer detections while reducing the burden of surgical resections for benign disease. There is little high-grade evidence to guide clinicians on optimal lung nodule tissue sampling modalities. The number of novel technologies available for this purpose has rapidly expanded over the last decade, making it difficult for clinicians to assess their efficacy. Unfortunately, there is a wide variety of methods used to determine the accuracy of these technologies, making comparisons across studies impossible. This paper will provide an in-depth review of available data regarding advanced bronchoscopic technologies.


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