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Development and val...
Development and validation of a 25-Gene Panel urine test for prostate cancer diagnosis and potential treatment follow-up
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- Johnson, Heather (author)
- Olympia Diagnostics, Inc., Sunnyvale, CA, USA
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- Guo, Jinan (author)
- Department of Urology, The Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen Urology Minimally Invasive Engineering Centre, Shenzhen, China; Shenzhen Public Service Platform on Tumor Precision Medicine and Molecular Diagnosis, Clinical Medical Research Centre, The Second Clinical College of Jinan University, Shenzhen People's Hospital, Shenzhen, China
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- Xuhui, Zhang (author)
- Department of Bio-diagnosis, Institute of Basic Medical Sciences, Beijing, China
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- Zhang, Heqiu (author)
- Department of Bio-diagnosis, Institute of Basic Medical Sciences, Beijing, China
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- Simoulis, Athanasios (author)
- Department of Clinical Pathology and Cytology, Skåne University Hospital, Malmö, Sweden
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- Wu, Alan H. B. (author)
- Clinical Laboratories, San Francisco General Hospital, San Francisco, CA, USA
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- Xia, Taolin (author)
- Department of Urology, Foshan First People's Hospital, Foshan, China
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- Li, Fei (author)
- Department of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, China
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- Tan, Wanlong (author)
- Department of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, China
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- Johnson, Allan (author)
- Kinetic Reality, Santa Clara, CA, USA
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- Dizeyi, Nishtman (author)
- Lund University,Lunds universitet,Molekylärgenetisk reproduktionsmedicin, Malmö,Forskargrupper vid Lunds universitet,Molecular genetic reproductive medicine, Malmö,Lund University Research Groups
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- Abrahamsson, Per Anders (author)
- Lund University,Lunds universitet,Urologi, Malmö (Abrahamsson),Forskargrupper vid Lunds universitet,Urological research, Malmö,Lund University Research Groups
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- Kenner, Lukas (author)
- Department of Experimental Pathology, Medical University Vienna & Unit of Laboratory Animal Pathology, University of Veterinary Medicine, Vienna, Austria
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- Feng, Xiaoyan (author)
- Department of Bio-diagnosis, Institute of Basic Medical Sciences, Beijing, China
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- Zou, Chang (author)
- Shenzhen Public Service Platform on Tumor Precision Medicine and Molecular Diagnosis, Clinical Medical Research Centre, The Second Clinical College of Jinan University, Shenzhen People's Hospital, Shenzhen, China
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- Xiao, Kefeng (author)
- Department of Urology, The Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen Urology Minimally Invasive Engineering Centre, Shenzhen, China; Shenzhen Public Service Platform on Tumor Precision Medicine and Molecular Diagnosis, Clinical Medical Research Centre, The Second Clinical College of Jinan University, Shenzhen People's Hospital, Shenzhen, China
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- Persson, Jenny L., Professor, 1964- (author)
- Lund University,Lunds universitet,Umeå University,Malmö University,Malmö universitet,Umeå universitet,Institutionen för molekylärbiologi (Medicinska fakulteten),Department of Molecular Biology, Umeå University, 901 87, Umeå, Sweden; Division of Experimental Cancer Research, Department of Translational Medicine, Lund University, 205 02, Malmö, Sweden,Jenny Persson,Institutionen för biomedicinsk vetenskap (BMV),Biofilms Research Center for Biointerfaces,Experimentell cancerforskning, Malmö,Forskargrupper vid Lunds universitet,Experimental Cancer Research, Malmö,Lund University Research Groups
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- Chen, Lingwu (author)
- Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, Guangdong, China
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Olympia Diagnostics, Inc, Sunnyvale, CA, USA Department of Urology, The Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen Urology Minimally Invasive Engineering Centre, Shenzhen, China; Shenzhen Public Service Platform on Tumor Precision Medicine and Molecular Diagnosis, Clinical Medical Research Centre, The Second Clinical College of Jinan University, Shenzhen People's Hospital, Shenzhen, China (creator_code:org_t)
- 2020-12-01
- 2020
- English.
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In: BMC Medicine. - : BioMed Central. - 1741-7015. ; 18
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Abstract
Subject headings
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- Background: Heterogeneity of prostate cancer (PCa) contributes to inaccurate cancer screening and diagnosis, unnecessary biopsies, and overtreatment. We intended to develop non-invasive urine tests for accurate PCa diagnosis to avoid unnecessary biopsies. Methods: Using a machine learning program, we identified a 25-Gene Panel classifier for distinguishing PCa and benign prostate. A non-invasive test using pre-biopsy urine samples collected without digital rectal examination (DRE) was used to measure gene expression of the panel using cDNA preamplification followed by real-time qRTPCR. The 25-Gene Panel urine test was validated in independent multi-center retrospective and prospective studies. The diagnostic performance of the test was assessed against the pathological diagnosis from biopsy by discriminant analysis. Uni- and multivariate logistic regression analysis was performed to assess its diagnostic improvement over PSA and risk factors. In addition, the 25-Gene Panel urine test was used to identify clinically significant PCa. Furthermore, the 25-Gene Panel urine test was assessed in a subset of patients to examine if cancer was detected after prostatectomy. Results: The 25-Gene Panel urine test accurately detected cancer and benign prostate with AUC of 0.946 (95% CI 0.963–0.929) in the retrospective cohort (n = 614), AUC of 0.901 (0.929–0.873) in the prospective cohort (n = 396), and AUC of 0.936 (0.956–0.916) in the large combination cohort (n = 1010). It greatly improved diagnostic accuracy over PSA and risk factors (p < 0.0001). When it was combined with PSA, the AUC increased to 0.961 (0.980–0.942). Importantly, the 25-Gene Panel urine test was able to accurately identify clinically significant and insignificant PCa with AUC of 0.928 (95% CI 0.947–0.909) in the combination cohort (n = 727). In addition, it was able to show the absence of cancer after prostatectomy with high accuracy. Conclusions: The 25-Gene Panel urine test is the first highly accurate and non-invasive liquid biopsy method without DRE for PCa diagnosis. In clinical practice, it may be used for identifying patients in need of biopsy for cancer diagnosis and patients with clinically significant cancer for immediate treatment, and potentially assisting cancer treatment follow-up.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Keyword
- machine learning
- liquid biopsy
- prostate cancer
- diagnostics
- Oncology
- onkologi
- Medicine
- medicin
- molekylär medicin (genetik och patologi)
- molecular medicine (genetics and pathology)
- Computer Systems
- datorteknik
- Clinically significant prostate cancer
- Gene Panel
- Prostate cancer
- Prostate cancer diagnosis
- Prostate cancer treatment follow-up
- Urine test
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Johnson, Heather
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Guo, Jinan
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Xuhui, Zhang
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Zhang, Heqiu
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Simoulis, Athana ...
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Wu, Alan H. B.
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show more...
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Xia, Taolin
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Li, Fei
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Tan, Wanlong
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Johnson, Allan
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Dizeyi, Nishtman
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Abrahamsson, Per ...
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Kenner, Lukas
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Feng, Xiaoyan
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Zou, Chang
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Xiao, Kefeng
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Persson, Jenny L ...
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Chen, Lingwu
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Urology and Neph ...
- Articles in the publication
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BMC Medicine
- By the university
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Umeå University
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Malmö University
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Lund University