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Biomarker-Based Tools for Treatment Response Decision Support of Bladder Cancer

Funder: National Cancer Institute

Funding period
USD 653 K
Funding amount
PROJECT SUMMARY / ABSTRACT Bladder cancer is a common type of cancer that can cause substantial morbidity and mortality among both men and women. Bladder cancer causes over 16,870 deaths per year in the United States with 79,030 new bladder cancer cases diagnosed in 2017. A reliable assessment of the response to neoadjuvant therapy at an early stage is vital for identifying tumors that do not respond and allowing the patient a chance of alternative treatment. We have successfully developed a computer decision support system (CDSS-T) for monitoring of bladder cancer treatment response. A quantitative image analysis tool for bladder cancer (QIBC) that quantifies the bladder gross tumor volume (GTV) and image characteristics is an important component of CDSS-T. Advanced machine learning techniques are used to merge the GTV and radiomic biomarkers into an effective predictive model. The goal of this project is to validate the effectiveness of CDSS-T as an aid to the radiologists and the oncologists in assessment of bladder cancer change as a result of treatment through pilot clinical trials. We will (1) perform a preparatory clinical trial with the clinicians at UM, which will simulate the real prospective clinical trial with high quality retrospective data, (2) deploy the QIBC and CDSS-T tools at the three collaborating clinical sites, (3) use the QIBC and CDSS-T tools at the different clinical sites in the prospective pilot clinical trial (standard clinical workflow) utilizing the decision support in parallel to the standard clinical patient care, and (4) analyze the impact of the QIBC and CDSS-T tools on the clinicians' performance in the pilot clinical trial and assess the potential impact on clinical outcome. We hypothesize that this innovative approach can improve clinicians' accuracy, consistency and efficiency in bladder GTV estimation and assessment of treatment response. To test these hypotheses, we will perform the following specific tasks: (1) to evaluate the performance of the QIBC and CDSS-T tools on cases not previously used, new to the system, for both the prediction accuracy and the automatic standalone functionality, refine and optimize the design of the user interface based on clinicians' feedback after their hands-on experience with the system to ensure its practicality and robustness, familiarize clinicians with the performance of the CDSS-T tools and the interpretation of the CDSS-T outputs as a part of user training for the prospective pilot clinical trial, (2) to optimize the QIBC and CDSS-T tools for the clinical workflow at the different clinical sites based on the site clinicians' feedback in order to operate efficiently and in a standalone mode by clinicians, (3) to record the clinicians' predicted outcomes without and with the use of the tools during the pilot clinical trials, estimate the accuracy of assessing response to neoadjuvant chemotherapy in the current clinical treatment paradigm by comparing the estimated response to the histopathologically determined response after radical cystectomy, and (4) to statistically analyze the impact of the QIBC and CDSS-T tools on the performance of the clinicians in the pilot clinical trial and statistically assess the potential impact on clinical outcome.

USD 12.5 M
Aggregated funding amount
USD 697 K
Average funding amount
Project list item
Phase 1/2 Study of Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder - (ADAPT-BLADDER)

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Proteogenomic characterization of muscle invasive bladder cancer to identify mechanisms of resistance and targets for therapy

Bladder Cancer Advocacy Network to Seth P. Lerner, Susan Hilsenbeck, Matthew James Ellis, Keith Syson Chan, Jonathan Michael Levitt, Sung Yun Jung, Anna Malovannaya, Bing Zhang

USD 300,000
2017 - 2019
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Development of personalized surgical algorithms for muscle-invasive bladder cancer patients

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USD 437,828
2017 - 2019
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Development of Novel Noninvasive Tests for Prognostic Predictions for Bladder Cancer

Congressionally Directed Medical Research Programs to Vinata B Lokeshwar

USD 608,000
2016 - 2017
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Regulation of ATDC by TP63 and its role in bladder cancer

National Cancer Institute to PHILLIP L PALMBOS

USD 524,880
2016 - 2021
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Synergistic Immuno-Photo-Nanotherapy for Bladder Cancer

Congressionally Directed Medical Research Programs to Brant A. Inman

USD 624,398
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Non-invasive quantification of microcirculation heterogeneity as a biomarker for the diagnosis and response prediction of bladder cancer

Bladder Cancer Advocacy Network to Huyen Thanh Nguyen

USD 1,700
2015 - 2015
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Functional characterization of novel non-coding RNA transcripts in bladder cancer

Canadian Institutes of Health Research to Adrian Dilan Gunaratne, Jeffrey L. Wrana

USD 16,953
2015 - 2015
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Biomarkers for Staging and Treatment Response Monitoring of Bladder Cancer

National Cancer Institute to LUBOMIR M HADJIYSKI

USD 2,153,403
2014 - 2019
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Urinary Diversion Among Bladder Cancer Survivors: Cost, Complications, and QOL

National Cancer Institute to CARMIT KURN MCMULLEN

USD 3,080,828
2012 - 2018
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MRE11 as an Outcome Prediction Biomarker in Bladder Cancer Radiotherapy (MOBIBLART)

Cancer Research UK to Anne Kiltie

2012 - 2015
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Optical Imaging of Bladder Cancer with Molecular Contrast Agents

National Cancer Institute to JOSEPH C LIAO

USD 1,714,025
2011 - 2016
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Quantitative Molecular and Drug Sensitivity Analysis for Bladder Cancer

American Association For Cancer Research to Arnold I. Chin

USD 100,000
2010 - 2012
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Bladder Cancer Oncogenome Project

American Association For Cancer Research to Matthew Ivan Milowsky, Dean Bajorin, Gary K Schwartz, David Solit, Victor Reuter, Oscar Lin, Nicole Ishill, Bernard Bochner, Guido Dalbagni, S Machele Donat, Harry W Herr

USD 252,500
2009 - 2011
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