Evidence map›Paper›PMID 33256740›Full record

ArticleBMC medicine2020

Development and validation of a 25-Gene Panel urine test for prostate cancer diagnosis and potential treatment follow-up.

Heather Johnson, Jinan Guo, Xuhui Zhang, Heqiu Zhang, Athanasios Simoulis, Alan H B Wu, Taolin Xia, Fei Li, Wanlong Tan, Allan Johnson and 8 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.6field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. Urine-derived exosomal PSMA is a promising diagnostic biomarker for the detection of prostate cancer on initial biopsy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
  7. Article
  8. Article
  9. A 23-Gene Classifier urine test for prostate cancer prognosis.Clinical and translational medicine · 2021
    Article
  10. Article
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 4 countries.

Heather JohnsonOlympia Diagnostics, Inc., Sunnyvale, CA, USA.
Jinan GuoDepartment of Urology, The Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen Urology Minimally Invasive Engineering Centre, Shenzhen, China.
Xuhui ZhangDepartment of Bio-diagnosis, Institute of Basic Medical Sciences, Beijing, China.
Heqiu ZhangDepartment of Bio-diagnosis, Institute of Basic Medical Sciences, Beijing, China.
Athanasios SimoulisDepartment of Clinical Pathology and Cytology, Skåne University Hospital, Malmö, Sweden.
Alan H B WuClinical Laboratories, San Francisco General Hospital, San Francisco, CA, USA.
Taolin XiaDepartment of Urology, Foshan First People's Hospital, Foshan, China.
Fei LiDepartment of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Wanlong TanDepartment of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Allan JohnsonKinetic Reality, Santa Clara, CA, USA.
Nishtman DizeyiDepartment of Translational Medicine, Lund University, Clinical Research Centre, Malmö, Sweden.
Per-Anders AbrahamssonDepartment of Translational Medicine, Lund University, Clinical Research Centre, Malmö, Sweden.
Lukas KennerDepartment of Experimental Pathology, Medical University Vienna & Unit of Laboratory Animal Pathology, University of Veterinary Medicine, Vienna, Austria.
Xiaoyan FengDepartment of Bio-diagnosis, Institute of Basic Medical Sciences, Beijing, China.
Chang ZouShenzhen 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.
Kefeng XiaoDepartment of Urology, The Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen Urology Minimally Invasive Engineering Centre, Shenzhen, China.
Jenny L PerssonDepartment of Molecular Biology, Umeå University, 901 87, Umeå, Sweden. jenny.persson@umu.se.
Lingwu ChenDepartment of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, Guangdong, China. chenlwu@mail.sysu.edu.cn.
Institute of Basic Medical Sciences of the Chinese Academy of Medical SciencesJinan University · CNLund University · SENanfang Hospital · CNFirst People's Hospital of Foshan · CNOlympia Diagnostics (United States) · USSan Francisco General Hospital · USSkåne University Hospital · SESun Yat-sen University · CNUmeå University · SEUniversity of Veterinary Medicine Vienna · AT

Funding

Sanming Project of Medicine in Shenzhen SZSM201412014The Science and Technology Foundation of Shenzhen JCYJ20170307095620828, JCYJ20160422145718224, JCYJ20170412155231633, JSGG20170414104216477, and JCYJ20150402152130696The Shenzhen Urology Minimally Invasive Engineering Centre GCZX2015043016165448
6 · The paper itself

Abstract

backgroundHeterogeneity 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.

methodsUsing 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 qRT-PCR. 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.

resultsThe 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.

conclusionsThe 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.

Indexed as

AdultAgedAged, 80 and overBiomarkers, TumorEarly Detection of CancerFollow-Up StudiesHumansMaleMiddle AgedProstate-Specific AntigenProstatic NeoplasmsReproducibility of ResultsRetrospective StudiesBiomarkers, TumorProstate-Specific AntigenClinically significant prostate cancerGene PanelProstate cancerProstate cancer diagnosisProstate cancer treatment follow-upUrine test

Identifiers

PMID33256740
PMCPMC7706045
OpenAlexW3107134268

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.