A Pilot Study on the Potential of RNA-Associated to Urinary Vesicles as a Suitable Non-Invasive Source for Diagnostic Purposes in Bladder Cancer

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.

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Clinical Utility of Oncuria™, a Multiplexed Liquid Biopsy for the Non-Invasive Detection of Bladder Cancer—A Pilot Study

Diagnostics ◽

10.3390/diagnostics12010131 ◽

2022 ◽

Vol 12 (1) ◽

pp. 131

Author(s):

Kaoru Murakami ◽

Ian Pagano ◽

Hideki Furuya ◽

Timothy Daskivich ◽

Dave Mori ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Diagnostic Tests ◽

Cancer Surveillance ◽

Molecular Diagnostic ◽

International Studies ◽

Gross Hematuria ◽

Real World Data ◽

Non Invasive ◽

Clinical Scenarios

Oncuria™ is a validated quantitative multiplex immunoassay capable of detecting bladder cancer from a voided urine sample. Herein, we sought to determine whether Oncuria™ affects physicians’ use of non-invasive and invasive diagnostic tests for microhematuria, gross hematuria, and bladder cancer surveillance. We conducted a survey-based study to assess physician management of nine clinical scenarios involving real-world data from patients with gross hematuria, microhematuria, and bladder cancer on surveillance. We randomly sampled 15 practicing urologists and generated data including 135 patient-by-urologist interactions and 2160 decision points. Urologists recommended a selection of diagnostic tests and procedures before and after Oncuria™ results were provided. We assessed changes in provider use of non-invasive and invasive diagnostic tests after Oncuria™ results were provided. Over 90% of all urologists changed their diagnostic behavior in at least one patient case with the addition of Oncuria™ results. The total number of diagnostic procedures was reduced by 31% following the disclosure of a negative Oncuria™ test and 27% following the disclosure of a positive Oncuria™ test. This is pilot study has the potential to shed light on the analysis of our four large multicenter international studies deploying OncuriaTM. The Oncuria™ urine-based test, a molecular diagnostic capable of ruling out the presence of bladder cancer, reduces both unnecessary invasive and non-invasive diagnostics and has the potential to reduce costs and improve patient outcomes.

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Improved non-invasive diagnosis of Bladder Cancer: A large pilot study with electronic nose

European Urology Open Science ◽

10.1016/s2666-1683(20)30070-7 ◽

2020 ◽

Vol 19 ◽

pp. e79

Author(s):

P.F. Bassi ◽

L. Di Gianfrancesco ◽

M. Ragonese ◽

E. Sacco ◽

G. Palermo ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Electronic Nose ◽

Non Invasive

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926: A Pilot Study to Determine Local Oxygen Saturation of the Flaccid and Erect Penis in Men with and without Erectile Dysfunction Using a Non-Invasive Tissue Oximeter

The Journal of Urology ◽

10.1016/s0022-5347(18)33162-8 ◽

2006 ◽

Vol 175 (4S) ◽

pp. 300-300 ◽

Cited By ~ 1

Author(s):

Priya Padmanabhan ◽

Andrew R. McCullough

Keyword(s):

Erectile Dysfunction ◽

Pilot Study ◽

Oxygen Saturation ◽

Non Invasive ◽

Local Oxygen ◽

Erect Penis

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Non-Invasive Distinction of Non-Alcoholic Fatty Liver Disease using Urinary Volatile Organic Compound Analysis: Early Results

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld.2014.1121.242.ury ◽

2015 ◽

Vol 24 (2) ◽

pp. 197-201 ◽

Cited By ~ 10

Author(s):

Ramesh P. Arasaradnam ◽

Michael McFarlane ◽

Emma Daulton ◽

Erik Westenbrink ◽

Nicola O’Connell ◽

...

Keyword(s):

Liver Disease ◽

Pilot Study ◽

Fatty Liver ◽

Fatty Liver Disease ◽

Diagnostic Methods ◽

Screening Methods ◽

Alcoholic Fatty Liver ◽

Non Invasive ◽

Volatile Organic ◽

Alcoholic Fatty Liver Disease

Background & Aims: Non-Alcoholic Fatty Liver Disease (NAFLD) is the commonest cause of chronic liver disease in the western world. Current diagnostic methods including Fibroscan have limitations, thus there is a need for more robust non-invasive screening methods. The gut microbiome is altered in several gastrointestinal and hepatic disorders resulting in altered, unique gut fermentation patterns, detectable by analysis of volatile organic compounds (VOCs) in urine, breath and faeces. We performed a proof of principle pilot study to determine if progressive fatty liver disease produced an altered urinary VOC pattern; specifically NAFLD and Non-Alcoholic Steatohepatitis (NASH).Methods: 34 patients were recruited: 8 NASH cirrhotics (NASH-C); 7 non-cirrhotic NASH; 4 NAFLD and 15 controls. Urine was collected and stored frozen. For assay, the samples were defrosted and aliquoted into vials, which were heated to 40±0.1°C and the headspace analyzed by FAIMS (Field Asymmetric Ion Mobility Spectroscopy). A previously used data processing pipeline employing a Random Forrest classification algorithm and using a 10 fold cross validation method was applied.Results: Urinary VOC results demonstrated sensitivity of 0.58 (0.33 - 0.88), but specificity of 0.93 (0.68 - 1.00) and an Area Under Curve (AUC) 0.73 (0.55 -0.90) to distinguish between liver disease and controls. However, NASH/NASH-C was separated from the NAFLD/controls with a sensitivity of 0.73 (0.45 - 0.92), specificity of 0.79 (0.54 - 0.94) and AUC of 0.79 (0.64 - 0.95), respectively.Conclusions: This pilot study suggests that urinary VOCs detection may offer the potential for early non-invasive characterisation of liver disease using 'smell prints' to distinguish between NASH and NAFLD.

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