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Project

Volatile OrganIc compounDs in Bladder Cancer (VOID Bladder Cancer)

Funder: Cancer Research UK

Funding period
0
Funding amount
Abstract
BackgroundUrothelial bladder cancer (UBC) is common. Recurrence after initial treatment is also common. Patients are required to undergo regular check cystoscopies to re-examine their bladder, as there are no tests for surveillance that have been found adequate for the purpose.AimsThe aim of this proposal is to develop a urinary biomarker signature for recurrent bladder cancer based on urinary volatile organic compounds (VOCs). In a pilot study, we found the VOC signatures for UBC appeared to have sensitivity of 95.8% and specificity of 94.6%. In that study, we focused on new cancers and the control group had other urology problems, mostly with haematuria. In order to develop a tool for surveillance, we will compare patients who have cancer (new and recurrent cases) with those patients undergoing surveillance in whom there is no recurrence, so that we can determine the potential for VOCs signature to be used in surveillance.MethodUrine samples will be collected by a dedicated technician: 180 with cancer and 360 controls. Six aliquots of each sample will be used for VOC research: 3 will be analysed after the addition of NaOH, 3 more after freeze drying. Thus, each preparation will be run in triplicate on the Odoreader device. The VOC signatures will be compared for patients with and without cancer, for each of the two methods of preparation. Statistical models with be prepared and tested, by experienced biomarker statisticians and a bioinformatician, using state of the art tools including boot-strapping, then applied to a validation set. The sensitivity, specificity, PPV, NPV and AUROC, as well as confidence intervals, to assess the precision of the parameters? estimates will be calculated and reported.How the results of this research will be usedIt is anticipated that the results of this study will form that basis of a multi-centre prospective, validation study that compares the diagnosis made by Odoreader with a findings at surveillance cystoscopy. Commercialisation of Odoreader for bladder cancer will follow. Its role then will be to reduce the need cystoscopy by providing an interval test, as recommended by NICE.
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System

Categories
  • FOR (ANZSRC)

    1112 Oncology and Carcinogenesis

  • RCDC

    Cancer

  • RCDC

    Clinical Research

  • RCDC

    Urologic Diseases

  • HRCS HC

    Cancer

  • HRCS RAC

    4.2 Evaluation of markers and technologies

  • Health Research Areas

    Clinical